Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT04864795
Eligibility Criteria:
Inclusion Criteria:
1. Adult aged ≥18 years at enrolment.
2. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
3. Patient has at least 1 record of LVEF documented in patient medical record in the 24 months prior to signature of informed consent. NOTE: If the proportion of patients with HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.
4. Patient treated with ACEi/ARB/ARNi at enrolment.
5. Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.
6. Patient at increased risk of hyperkalaemia due to one or more of the following:
1. Current hyperkalaemia (sK+ \>5.0 mEq/l) at enrolment
2. Record of documented hyperkalaemia (sK+ \>5.0 mEq/l) in the 24 months prior to signature of informed consent
3. eGFR \<45 ml/min/1.73 m2, or CKD Stage ≥3b.
7. Patient judged by the Investigator to have sufficient cognitive ability to participate.
8. Signed informed consent provided
Exclusion Criteria:
1. Patient on renal replacement therapy or mechanical circulatory support.
2. Disease other than HF with expected survival \<1 year.
3. Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.
4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04864795
Study Brief:
Protocol Section:
NCT04864795