Evidence Based Medicine on FHIR Implementation Guide
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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

Example Group: NCT03640312 Eligibility Criteria

version: 26; Last updated: 2025-08-18 13:22:42+0000

Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

CiteAs:

NCT03640312 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367881. Revised 2025-08-18. Available at: https://fevir.net/resources/Group/367881. Computable resource at: https://fevir.net/resources/Group/367881#json.

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Group/367881

identifier: FEvIR Object Identifier/367881, FEvIR Linking Identifier/NCT03640312 Eligibility Criteria

name: NCT03640312_Eligibility_Criteria

title: NCT03640312 Eligibility Criteria

status: Active

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

description:

Inclusion Criteria:

  • Adults (≥18 years)
  • Spanish or English speaker.
  • Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).
  • Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.
  • Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.
  • Research grade blood pressure measurement (baseline mean) SBP>= 115 mmHg and DBP >= 60 mmHg

Exclusion Criteria:

  • Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.
  • Previous diagnosis of coronary artery disease, stroke, or heart failure.
  • Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)
  • Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).
  • Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).
  • Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.
  • Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
  • Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.
  • Inability or unwillingness to provide written informed consent.
  • Unable to complete study procedures.

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

membership: Conceptual

combinationMethod: All of

characteristic

code: Eligibility Criteria

value: Inclusion Criteria: * Adults (≥18 years) * Spanish or English speaker. * Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse). * Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks. * Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose. * Research grade blood pressure measurement (baseline mean) SBP\>= 115 mmHg and DBP \>= 60 mmHg Exclusion Criteria: * Known contraindication to candesartan, amlodipine, indapamide or bisoprolol. * Previous diagnosis of coronary artery disease, stroke, or heart failure. * Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g) * Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L). * Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods). * Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments. * Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible. * Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy. * Inability or unwillingness to provide written informed consent. * Unable to complete study procedures.

exclude: false

characteristic

code: Accepts Healthy Volunteers

value: false

exclude: false

characteristic

code: Age

value: 18-? year

exclude: false

characteristic

code: Age Group

value: Adult or Older Adult

exclude: false