Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ResearchStudy 367879</b></p><a name="367879"> </a><a name="hc367879"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 29; Last updated: 2025-08-18 13:22:42+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-study-registry-record.html">StudyRegistryRecord</a></p></div><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-submission}">Registration submission</span></li><li>actual: true</li><li>period: 2018-08-15 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-submission}">Results submission</span></li><li>actual: true</li><li>period: 2023-05-31 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-submission-qc}">Registration submission Quality Check</span></li><li>actual: true</li><li>period: 2018-08-17 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-submission-qc}">Results submission Quality Check</span></li><li>actual: true</li><li>period: 2023-09-20 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity record-verification}">Record Verification</span></li><li>actual: true</li><li>period: ?? --> 2024-12</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity update-submission}">Update submission</span></li><li>actual: true</li><li>period: ?? --> 2024-12-16</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-posting}">Registration posting</span></li><li>actual: true</li><li>period: 2018-08-21 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-posting}">Results posting</span></li><li>actual: true</li><li>period: 2023-09-22 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity primary-outcome-data-collection}">Primary outcome data collection</span></li><li>actual: true</li><li>period: ?? --> 2022-05-31</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity update-posting}">Update posting</span></li><li>actual: true</li><li>period: ?? --> 2025-01-03</li></ul></blockquote><p><b>Artifact Author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/ResearchStudy/367879">https://fevir.net/resources/ResearchStudy/367879</a></p><p><b>identifier</b>: FEvIR Object Identifier/367879, <code>https://clinicaltrials.gov</code>/NCT03640312 (use: official, ), 202203097-STU00205834, FEvIR Linking Identifier/NCT03640312 FHIR Transform</p><p><b>name</b>: NCT03640312_FHIR_Transform</p><p><b>title</b>: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type official}">Official title</span></p><p><b>value</b>: A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA)</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/title-type acronym}">Acronym</span></p><p><b>value</b>: QUARTET USA</p></blockquote><p><b>citeAs</b>: </p><div><p>Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367879. Revised 2025-08-18. Available at: https://fevir.net/resources/ResearchStudy/367879. Computable resource at: https://fevir.net/resources/ResearchStudy/367879#json.</p>
</div><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transforms</p><p><b>target</b>: <a href="https://clinicaltrials.gov/api/v2/studies/NCT03640312?format=json">https://clinicaltrials.gov/api/v2/studies/NCT03640312?format=json</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transformed With</p><p><b>target</b>: null @ https://fevir.net/resources/Project/29885</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cites</p><p><b>target</b>: <code>Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.</code></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Documentation</p><p><b>target</b>: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/12/NCT03640312/Prot_001.pdf</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Documentation</p><p><b>target</b>: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/12/NCT03640312/SAP_002.pdf</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Documentation</p><p><b>target</b>: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/12/NCT03640312/ICF_000.pdf</p></blockquote><p><b>status</b>: Active</p><p><b>primaryPurposeType</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type treatment}">Treatment</span></p><p><b>phase</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-phase phase-2}">Phase 2</span></p><p><b>studyDesign</b>: <span title="Codes:">Design Masking: Quadruple</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01060}">Blinding of study participants</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01061}">Blinding of intervention providers</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01063}">Blinding of data analysts</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01062}">Blinding of outcome assessors</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01003}">randomized assignment</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01011}">Parallel cohort design</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01001}">interventional research</span></p><p><b>condition</b>: <span title="Codes:">Hypertension</span></p><p><b>keyword</b>: <span title="Codes:">Hypertension</span>, <span title="Codes:">Blood Pressure</span></p><p><b>descriptionSummary</b>: </p><div><p>To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension.</p>
<p>Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.</p>
</div><p><b>description</b>: </p><div><p>This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP>130 mmHg or DBP>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.</p>
<p>The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.</p>
<p>While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.</p>
</div><p><b>site</b>: </p><ul><li><a href="#hc367879/NCT03640312-Location-0">Location ACCESS Martin T. Russo Family Health Center</a></li><li><a href="#hc367879/NCT03640312-Location-1">Location Ashland Family Health Center</a></li></ul><p><b>classifier</b>: <span title="Codes:">IPDSharing: Yes</span>, <span title="Codes:">IPDSharingDescription: Individual participant data will be shared through NHLBI BioLINCC.</span>, <span title="Codes:">IPDSharingInfoType: Study Protocol</span>, <span title="Codes:">IPDSharingInfoType: Statistical Analysis Plan (SAP)</span>, <span title="Codes:">IPDSharingInfoType: Informed Consent Form (ICF)</span>, <span title="Codes:">IPDSharingInfoType: Clinical Study Report (CSR)</span>, <span title="Codes:">IPDSharingInfoType: Analytic Code</span>, <span title="Codes:">IPDSharingTimeFrame: Data will be available within 1 year of study conclusion.</span>, <span title="Codes:">IPDSharingAccessCriteria: Access to study data will be managed through NHLBI BioLINCC</span>, <span title="Codes:">Has Results: True</span>, <span title="Codes:">Oversight Classifier: oversightHasDmc True</span>, <span title="Codes:">Oversight Classifier: isFdaRegulatedDrug True</span>, <span title="Codes:">Oversight Classifier: isFdaRegulatedDevice False</span>, <span title="Codes:">AgreementPISponsorEmployee: False</span>, <span title="Codes:">AgreementRestrictiveAgreement: False</span></p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Washington University School of Medicine</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role sponsor}">Sponsor</span></p><p><b>classifier</b>: <span title="Codes:">OTHER</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Mark Huffman</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role primary-investigator}">Principal investigator</span></p><p><b>party</b>: <a href="#hc367879/NCT03640312-ResponsibleParty-0">PractitionerRole </a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Washington University School of Medicine</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role lead-sponsor}">Lead sponsor</span></p><p><b>classifier</b>: <span title="Codes:">OTHER</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: ACCESS Community Health Network</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role collaborator}">Collaborator</span></p><p><b>classifier</b>: <span title="Codes:">OTHER</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: University of Sydney</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role collaborator}">Collaborator</span></p><p><b>classifier</b>: <span title="Codes:">OTHER</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Mark D Huffman, PhD, MD</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role primary-investigator}">Principal investigator</span></p><p><b>party</b>: Northwestern University Feinberg School of Medicine</p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Jody D Ciolino, PhD</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role primary-investigator}">Principal investigator</span></p><p><b>party</b>: Overall Study Officials:</p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://hl7.org/fhir/research-study-status completed}">Completed</span></p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://hl7.org/fhir/research-study-status overall-study}">Overall study</span></p><p><b>actual</b>: true</p><p><b>period</b>: 2019-08-30 --> 2024-07-31</p></blockquote><h3>Recruitments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ActualNumber</b></td><td><b>Eligibility</b></td></tr><tr><td style="display: none">*</td><td>62</td><td><a href="Group-367881.html">NCT03640312 Eligibility Criteria</a></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>eligibility</b>: <a href="#hc367879/NCT03640312-comparison-group-0">QUARTET LDQT: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.</a></p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>eligibility</b>: <a href="#hc367879/NCT03640312-comparison-group-1">Candesartan: Patients randomized to the comparison arm will take a once daily 8mg candesartan.</a></p></blockquote><blockquote><p><b>objective</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></p><h3>OutcomeMeasures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Description</b></td><td><b>Endpoint</b></td></tr><tr><td style="display: none">*</td><td>Change in Mean Systolic Blood Pressure</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></td><td><div><p>Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.</p>
</div></td><td><a href="EvidenceVariable-367882.html">EvidenceVariable Change in Mean Systolic Blood Pressure (NCT03640312)</a></td></tr></table></blockquote><blockquote><p><b>objective</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Systolic Blood Pressure</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Mean automated office systolic blood pressure adjusted for baseline values.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367883.html">EvidenceVariable Mean Systolic Blood Pressure (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Change in Mean Diastolic Blood Pressure</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367884.html">EvidenceVariable Change in Mean Diastolic Blood Pressure (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Diastolic Blood Pressure</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Mean automated office diastolic blood pressure adjusted for baseline values.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367885.html">EvidenceVariable Mean Diastolic Blood Pressure (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Proportion of Patients With Hypertension Control</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Proportion of patients with hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg).</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367886.html">EvidenceVariable Proportion of Patients With Hypertension Control (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Number of Patients Requiring Step up Treatment</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Number of patients requiring step-up treatment.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367887.html">EvidenceVariable Number of Patients Requiring Step up Treatment (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Proportion of Patients With Adverse Event Free Hypertension Control</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Proportion of patients with adverse event free hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg).</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367888.html">EvidenceVariable Proportion of Patients With Adverse Event Free Hypertension Control (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Medication Adherence</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Medication adherence defined by objective pill counts</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367889.html">EvidenceVariable Medication Adherence (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Health-related Quality of Life</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367890.html">EvidenceVariable Health-related Quality of Life (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Change in Mean Systolic Blood Pressure</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367891.html">EvidenceVariable Change in Mean Systolic Blood Pressure (NCT03640312)</a></p></blockquote></blockquote><blockquote><p><b>objective</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Percentage of Participants With Serious Adverse Events (SAEs)</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367896.html">EvidenceVariable Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Percentage of Participants With Potentially Related Adverse Events</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367897.html">EvidenceVariable Percentage of Participants With Potentially Related Adverse Events (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Rate of Adverse Events of Special Interest</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367898.html">EvidenceVariable Rate of Adverse Events of Special Interest (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Change in Serum Potassium</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in continuous serum potassium.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367899.html">EvidenceVariable Mean Change in Serum Potassium (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Change in Serum Sodium</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in continuous serum sodium.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367900.html">EvidenceVariable Mean Change in Serum Sodium (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Change in Blood Urea Nitrogen</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Mean change (from baseline) in continuous blood urea nitrogen.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367901.html">EvidenceVariable Mean Change in Blood Urea Nitrogen (NCT03640312)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Mean Change in Serum Creatinine</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type exploratory}">Exploratory</span></p><p><b>description</b>: </p><div><p>Mean change in continuous serum creatinine.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-367902.html">EvidenceVariable Mean Change in Serum Creatinine (NCT03640312)</a></p></blockquote></blockquote><p><b>result</b>: <a href="Composition-367880.html">Results Section for NCT03640312</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-drug------quartet-ldqt</b></p><a name="367879/NCT03640312-drug------quartet-ldqt"> </a><a name="hc367879/NCT03640312-drug------quartet-ldqt"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>name</b>: NCT03640312_drug______quartet_ldqt</p><p><b>title</b>: QUARTET LDQT</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p>
</div><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Intervention Type: DRUG</span></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-drug------candesartan</b></p><a name="367879/NCT03640312-drug------candesartan"> </a><a name="hc367879/NCT03640312-drug------candesartan"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>name</b>: NCT03640312_drug______candesartan</p><p><b>title</b>: Candesartan</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p>
</div><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Intervention Type: DRUG</span></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #NCT03640312-comparison-group-0</b></p><a name="367879/NCT03640312-comparison-group-0"> </a><a name="hc367879/NCT03640312-comparison-group-0"> </a><p><b>Artifact Author</b>: Computable Publishing®: [System]-to-FEvIR Converter: </p><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-comparison-group-0</p><p><b>title</b>: NCT03640312 Comparison Group: QUARTET LDQT</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.</p>
</div><p><b>membership</b>: Conceptual</p><p><b>code</b>: <span title="Codes:">Experimental</span></p><h3>Characteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Exposed to</span></td><td><a href="#hc367879/NCT03640312-drug------quartet-ldqt">Drug: QUARTET LDQT</a></td><td>false</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #NCT03640312-comparison-group-1</b></p><a name="367879/NCT03640312-comparison-group-1"> </a><a name="hc367879/NCT03640312-comparison-group-1"> </a><p><b>Artifact Author</b>: Computable Publishing®: [System]-to-FEvIR Converter: </p><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-comparison-group-1</p><p><b>title</b>: NCT03640312 Comparison Group: Candesartan</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Patients randomized to the comparison arm will take a once daily 8mg candesartan.</p>
</div><p><b>membership</b>: Conceptual</p><p><b>code</b>: <span title="Codes:">Active Comparator</span></p><h3>Characteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Exposed to</span></td><td><a href="#hc367879/NCT03640312-drug------candesartan">Drug: Candesartan</a></td><td>false</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: PractitionerRole #NCT03640312-ResponsibleParty-0</b></p><a name="367879/NCT03640312-ResponsibleParty-0"> </a><a name="hc367879/NCT03640312-ResponsibleParty-0"> </a><p><b>practitioner</b>: Mark Huffman</p><p><b>organization</b>: Washington University School of Medicine</p><p><b>code</b>: <span title="Codes:">Professor of Medicine and Global Health Center Co-Director</span></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Location #NCT03640312-Location-0</b></p><a name="367879/NCT03640312-Location-0"> </a><a name="hc367879/NCT03640312-Location-0"> </a><p><b>name</b>: ACCESS Martin T. Russo Family Health Center</p><p><b>address</b>: Bloomingdale Illinois 60108 United States </p><h3>Positions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Longitude</b></td><td><b>Latitude</b></td></tr><tr><td style="display: none">*</td><td>-88.0809</td><td>41.95753</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Location #NCT03640312-Location-1</b></p><a name="367879/NCT03640312-Location-1"> </a><a name="hc367879/NCT03640312-Location-1"> </a><p><b>name</b>: Ashland Family Health Center</p><p><b>address</b>: Chicago Illinois 60609 United States </p><h3>Positions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Longitude</b></td><td><b>Latitude</b></td></tr><tr><td style="display: none">*</td><td>-87.65005</td><td>41.85003</td></tr></table></blockquote></div>
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<text value="Hypertension"/>
</keyword>
<keyword>
<text value="Blood Pressure"/>
</keyword>
<descriptionSummary
value="To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension.
Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations."/>
<description
value="This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP\>130 mmHg or DBP\>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.
The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.
While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians."/>
<site>
<reference value="#NCT03640312-Location-0"/>
<type value="Location"/>
</site>
<site>
<reference value="#NCT03640312-Location-1"/>
<type value="Location"/>
</site>
<classifier>
<text value="IPDSharing: Yes"/>
</classifier>
<classifier>
<text
value="IPDSharingDescription: Individual participant data will be shared through NHLBI BioLINCC."/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Study Protocol"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Statistical Analysis Plan (SAP)"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Informed Consent Form (ICF)"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Clinical Study Report (CSR)"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Analytic Code"/>
</classifier>
<classifier>
<text
value="IPDSharingTimeFrame: Data will be available within 1 year of study conclusion."/>
</classifier>
<classifier>
<text
value="IPDSharingAccessCriteria: Access to study data will be managed through NHLBI BioLINCC"/>
</classifier>
<classifier>
<text value="Has Results: True"/>
</classifier>
<classifier>
<text value="Oversight Classifier: oversightHasDmc True"/>
</classifier>
<classifier>
<text value="Oversight Classifier: isFdaRegulatedDrug True"/>
</classifier>
<classifier>
<text value="Oversight Classifier: isFdaRegulatedDevice False"/>
</classifier>
<classifier>
<text value="AgreementPISponsorEmployee: False"/>
</classifier>
<classifier>
<text value="AgreementRestrictiveAgreement: False"/>
</classifier>
<associatedParty>
<name value="Washington University School of Medicine"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="sponsor"/>
<display value="Sponsor"/>
</coding>
</role>
<classifier>
<text value="OTHER"/>
</classifier>
</associatedParty>
<associatedParty>
<name value="Mark Huffman"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="primary-investigator"/>
<display value="Principal investigator"/>
</coding>
</role>
<party>
<reference value="#NCT03640312-ResponsibleParty-0"/>
<type value="PractitionerRole"/>
</party>
</associatedParty>
<associatedParty>
<name value="Washington University School of Medicine"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="lead-sponsor"/>
<display value="Lead sponsor"/>
</coding>
</role>
<classifier>
<text value="OTHER"/>
</classifier>
</associatedParty>
<associatedParty>
<name value="ACCESS Community Health Network"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="collaborator"/>
<display value="Collaborator"/>
</coding>
</role>
<classifier>
<text value="OTHER"/>
</classifier>
</associatedParty>
<associatedParty>
<name value="University of Sydney"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="collaborator"/>
<display value="Collaborator"/>
</coding>
</role>
<classifier>
<text value="OTHER"/>
</classifier>
</associatedParty>
<associatedParty>
<name value="Mark D Huffman, PhD, MD"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="primary-investigator"/>
<display value="Principal investigator"/>
</coding>
</role>
<party>
<display value="Northwestern University Feinberg School of Medicine"/>
</party>
</associatedParty>
<associatedParty>
<name value="Jody D Ciolino, PhD"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="primary-investigator"/>
<display value="Principal investigator"/>
</coding>
</role>
<party>
<display value="Overall Study Officials:"/>
</party>
</associatedParty>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="completed"/>
<display value="Completed"/>
</coding>
</state>
</progressStatus>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="overall-study"/>
<display value="Overall study"/>
</coding>
</state>
<actual value="true"/>
<period>
<start value="2019-08-30"/>
<end value="2024-07-31"/>
</period>
</progressStatus>
<recruitment>
<actualNumber value="62"/>
<eligibility>🔗
<reference value="Group/367881"/>
<type value="Group"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312 Eligibility Criteria"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="NCT03640312 Eligibility Criteria"/>
</eligibility>
</recruitment>
<comparisonGroup>
<eligibility>
<reference value="#NCT03640312-comparison-group-0"/>
<type value="Group"/>
<display
value="QUARTET LDQT: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States."/>
</eligibility>
</comparisonGroup>
<comparisonGroup>
<eligibility>
<reference value="#NCT03640312-comparison-group-1"/>
<type value="Group"/>
<display
value="Candesartan: Patients randomized to the comparison arm will take a once daily 8mg candesartan."/>
</eligibility>
</comparisonGroup>
<objective>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<outcomeMeasure>
<name value="Change in Mean Systolic Blood Pressure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<description
value="Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values."/>
<endpoint>🔗
<reference value="EvidenceVariable/367882"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-primaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
</objective>
<objective>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<outcomeMeasure>
<name value="Mean Systolic Blood Pressure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Mean automated office systolic blood pressure adjusted for baseline values."/>
<endpoint>🔗
<reference value="EvidenceVariable/367883"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Change in Mean Diastolic Blood Pressure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values."/>
<endpoint>🔗
<reference value="EvidenceVariable/367884"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Mean Diastolic Blood Pressure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Mean automated office diastolic blood pressure adjusted for baseline values."/>
<endpoint>🔗
<reference value="EvidenceVariable/367885"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Proportion of Patients With Hypertension Control"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Proportion of patients with hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg)."/>
<endpoint>🔗
<reference value="EvidenceVariable/367886"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Number of Patients Requiring Step up Treatment"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description value="Number of patients requiring step-up treatment."/>
<endpoint>🔗
<reference value="EvidenceVariable/367887"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Proportion of Patients With Adverse Event Free Hypertension Control"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg)."/>
<endpoint>🔗
<reference value="EvidenceVariable/367888"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-5"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Medication Adherence"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Medication adherence defined by objective pill counts"/>
<endpoint>🔗
<reference value="EvidenceVariable/367889"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Health-related Quality of Life"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline."/>
<endpoint>🔗
<reference value="EvidenceVariable/367890"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-7"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Change in Mean Systolic Blood Pressure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values."/>
<endpoint>🔗
<reference value="EvidenceVariable/367891"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-secondaryOutcome-8"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
</objective>
<objective>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<outcomeMeasure>
<name
value="Percentage of Participants With Serious Adverse Events (SAEs)"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above."/>
<endpoint>🔗
<reference value="EvidenceVariable/367896"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="Percentage of Participants With Potentially Related Adverse Events"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug."/>
<endpoint>🔗
<reference value="EvidenceVariable/367897"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Rate of Adverse Events of Special Interest"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level."/>
<endpoint>🔗
<reference value="EvidenceVariable/367898"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Mean Change in Serum Potassium"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Mean change (from baseline) in continuous serum potassium."/>
<endpoint>🔗
<reference value="EvidenceVariable/367899"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Mean Change in Serum Sodium"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Mean change (from baseline) in continuous serum sodium."/>
<endpoint>🔗
<reference value="EvidenceVariable/367900"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Mean Change in Blood Urea Nitrogen"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Mean change (from baseline) in continuous blood urea nitrogen."/>
<endpoint>🔗
<reference value="EvidenceVariable/367901"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-5"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name value="Mean Change in Serum Creatinine"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description value="Mean change in continuous serum creatinine."/>
<endpoint>🔗
<reference value="EvidenceVariable/367902"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312-otherOutcome-6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
</objective>
<result>🔗
<reference value="Composition/367880"/>
<type value="Composition"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03640312 Results Report"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="Results Section for NCT03640312"/>
</result>
</ResearchStudy>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-09-04
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