Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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-ballot3 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: 29; Last updated: 2026-09-02 17:12:13+0000

ArtifactPublicationStatus: Active

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 2026-09-02. Available at: https://fevir.net/resources/Group/367881. Computable resource at: https://fevir.net/resources/Group/367881#json.

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:

Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).

membership: Conceptual

combinationMethod: All of

characteristic

code: Defined by CodeableConcept

value: Adults (≥18 years)

exclude: false

description:

Adults (≥18 years)

characteristic

code: Defined by CodeableConcept

value: Spanish or English speaker.

exclude: false

description:

Spanish or English speaker.

characteristic

code: Defined by CodeableConcept

value: 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).

exclude: false

description:

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).

characteristic

code: Defined by CodeableConcept

value: 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.

exclude: false

description:

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.

characteristic

code: Defined by CodeableConcept

value: 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.

exclude: false

description:

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.

characteristic

code: Defined by CodeableConcept

value: Research grade blood pressure measurement (baseline mean) SBP\>= 115 mmHg and DBP \>= 60 mmHg

exclude: false

description:

Research grade blood pressure measurement (baseline mean) SBP>= 115 mmHg and DBP >= 60 mmHg

characteristic

code: Defined by CodeableConcept

value: Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.

exclude: true

description:

Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.

characteristic

code: Defined by CodeableConcept

value: Previous diagnosis of coronary artery disease, stroke, or heart failure.

exclude: true

description:

Previous diagnosis of coronary artery disease, stroke, or heart failure.

characteristic

code: Defined by CodeableConcept

value: 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)

exclude: true

description:

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)

characteristic

code: Defined by CodeableConcept

value: 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).

exclude: true

description:

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).

characteristic

code: Defined by CodeableConcept

value: 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).

exclude: true

description:

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).

characteristic

code: Defined by CodeableConcept

value: 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.

exclude: true

description:

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.

characteristic

code: Defined by CodeableConcept

value: 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.

exclude: true

description:

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.

characteristic

code: Defined by CodeableConcept

value: Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.

exclude: true

description:

Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.

characteristic

code: Defined by CodeableConcept

value: Inability or unwillingness to provide written informed consent.

exclude: true

description:

Inability or unwillingness to provide written informed consent.

characteristic

code: Defined by CodeableConcept

value: Unable to complete study procedures.

exclude: true

description:

Unable to complete study procedures.