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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT03168568
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years of age, male or female, with a diagnosis of symptomatic heart failure (NYHA class II-IV) per ESC heart failure guidelines
2. LVEF ≤ 40%
3. Established guideline-recommended therapy with an ACEI, ARB and a beta-blocker, as clinically indicated and tolerated, at stable doses for at least 3 weeks prior to inclusion.
Exclusion Criteria:
1. History of hypersensitivity or allergy to any of the study drugs
2. History of angioedema.
3. Sitting systolic blood pressure \<90 mmHg at Visit 1 (screening) or Visit 2 (randomization)
4. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
5. Estimated GFR \< 20 mL/min/1.73m2
6. Serum potassium \> 5.5 mmol/L at Visit 1 (screening) or Visit 2 (randomization).
7. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.
8. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1.
9. Implantation of a cardiac resynchronization therapy device (CRTD) within 2 months prior Visit 1 or intent to implant a CRTD within next 3 months.
10. History of heart transplant, on a transplant list or with ventricular assistance device (VAD).
11. Presence of significant endocrine diseases.
12. Presence of active acute infectious diseases.
13. Known narrow-angle glaucoma
14. Known epilepsy
15. Cimino-shunt operation on both arms
16. Pregnancy, intention thereof during study; lack of sufficient contraception; breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03168568
Study Brief:
Protocol Section:
NCT03168568