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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT05623358
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form;
2. Stated willingness to comply with all study procedures and availability for the duration of the study;
3. Age ≥18 years;
4. Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening;
5. Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment;
6. Willingness to receive medications for the management of HFrEF;
7. Access to necessary resources for participating (telephone ± computer with internet access).
Exclusion Criteria:
1. Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening;
2. Lying/sitting systolic blood pressure \<90 mm Hg at time of enrolment;
3. Serum potassium ≥5.5 mmol/L at time of enrolment;
4. ≥2 measurements indicating estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 within 3 months prior to enrolment;
5. Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening;
6. Requiring diuretic dose greater than furosemide 80 mg equivalents or requiring the addition of a thiazide-like diuretic for more than 3 days at time of screening;
7. Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05623358
Study Brief:
Protocol Section:
NCT05623358