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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT03553303
Eligibility Criteria:
Inclusion Criteria:
1. Patients must give written informed consent before any study assessment is performed.
2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
4. Patients on optimized medical treatment for heart failure. -
Exclusion Criteria:
1. Patients not able to comply in the study.
2. Patients having contraindication for treatment with Entresto;
1. Hypersensitivity to the active substances or to any of the excipients listed in section
2. Hyperkalemia: \> 5.4 mmol/L
3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.
4. Hereditary or idiopathic angioedema.
5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2)
6. End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis).
7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
8. Pregnancy Breast-feeding-
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03553303
Study Brief:
Protocol Section:
NCT03553303