http://hl7.org/fhir/uv/ebm/ResearchStudy/367879
type: ResearchStudy
node role: treeRoot
id:
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meta:
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  last updated:
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    v: Generated Narrative: ResearchStudy 367879 version: 32; Last updated: 2025-09-13 13:13:52+0000; Language: en Profile: StudyRegistryRecord Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: url: https://fevir.net/resources/ResearchStudy/367879 identifier: FEvIR Object Identifier/367879, https://clinicaltrials.gov/NCT03640312 (use: official, ), 202203097-STU00205834, FEvIR Linking Identifier/NCT03640312 FHIR Transform name: NCT03640312_FHIR_Transform title: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension label type: Official title value: A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA) label type: Acronym value: QUARTET USA citeAs: 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 2025-09-13. Available at: https://fevir.net/resources/ResearchStudy/367879. Computable resource at: https://fevir.net/resources/ResearchStudy/367879#json. relatesTo type: Transforms target: https://clinicaltrials.gov/api/v2/studies/NCT03640312?format=json relatesTo type: Transformed With target: null @ https://fevir.net/resources/Project/29885 relatesTo type: Cites target: 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. PMID: 36116516; PMCID: PMC10236716. relatesTo type: Documenta…
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v: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension

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v: 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 2025-09-13. Available at: https://fevir.net/resources/ResearchStudy/367879. Computable resource at: https://fevir.net/resources/ResearchStudy/367879#json.

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  v: 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. PMID: 36116516; PMCID: PMC10236716.

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text:
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text:
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text:
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text:
  v: Blood Pressure

v: 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.

v: 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.

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  v: IPDSharing: Yes

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  v: IPDSharingTimeFrame: Data will be available within 1 year of study conclusion.

text:
  v: IPDSharingAccessCriteria: Access to study data will be managed through NHLBI BioLINCC

text:
  v: Has Results: True

text:
  v: Oversight Classifier: oversightHasDmc True

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text:
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text:
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name:
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period:
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  end:
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    v: 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.

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      display:
        v: Secondary
  description:
    v: Number of patients requiring step-up treatment.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367887
    reference:
      v: EvidenceVariable/367887
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcome-4
outcome measure:
  name:
    v: Proportion of Patients With Adverse Event Free Hypertension Control
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg).
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367888
    reference:
      v: EvidenceVariable/367888
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcome-5
outcome measure:
  name:
    v: Medication Adherence
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: Medication adherence defined by objective pill counts
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367889
    reference:
      v: EvidenceVariable/367889
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcome-6
outcome measure:
  name:
    v: Health-related Quality of Life

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

coding:
  system:
    v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
    l: research-study-objective-type
  code:
    v: secondary
  display:
    v: Secondary

v: 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.

l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367890
reference:
  v: EvidenceVariable/367890
type:
  v: EvidenceVariable
  l: EvidenceVariable
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT03640312-secondaryOutcome-7
  assigner:
    display:
      v: Computable Publishing LLC

name:
  v: Change in Mean Systolic Blood Pressure
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
      l: research-study-objective-type
    code:
      v: secondary
    display:
      v: Secondary
description:
  v: Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.
endpoint:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367891
  reference:
    v: EvidenceVariable/367891
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-secondaryOutcome-8
    assigner:
      display:
        v: Computable Publishing LLC

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
      l: research-study-objective-type
    code:
      v: exploratory
    display:
      v: Exploratory
outcome measure:
  name:
    v: Percentage of Participants With Serious Adverse Events (SAEs)
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: 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:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367896
    reference:
      v: EvidenceVariable/367896
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-0
outcome measure:
  name:
    v: Percentage of Participants With Potentially Related Adverse Events
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: 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:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367897
    reference:
      v: EvidenceVariable/367897
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-1
outcome measure:
  name:
    v: Rate of Adverse Events of Special Interest
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367898
    reference:
      v: EvidenceVariable/367898
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-2
outcome measure:
  name:
    v: Mean Change in Serum Potassium
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Mean change (from baseline) in continuous serum potassium.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367899
    reference:
      v: EvidenceVariable/367899
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-3
outcome measure:
  name:
    v: Mean Change in Serum Sodium
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Mean change (from baseline) in continuous serum sodium.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367900
    reference:
      v: EvidenceVariable/367900
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-4
outcome measure:
  name:
    v: Mean Change in Blood Urea Nitrogen
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Mean change (from baseline) in continuous blood urea nitrogen.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367901
    reference:
      v: EvidenceVariable/367901
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-5
outcome measure:
  name:
    v: Mean Change in Serum Creatinine
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Mean change in continuous serum creatinine.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367902
    reference:
      v: EvidenceVariable/367902
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-otherOutcome-6

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

l: http://hl7.org/fhir/uv/ebm/Composition/367880
reference:
  v: Composition/367880
type:
  v: Composition
  l: Composition
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT03640312 Results Report
  assigner:
    display:
      v: Computable Publishing LLC
display:
  v: Results Section for NCT03640312