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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT03917459
Eligibility Criteria:
Key Inclusion Criteria:
* Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF \< 40%)
* Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
* Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
* Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
* Patients must be literate in German
Key Exclusion Criteria:
* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
* Symptomatic hypotension
* Impaired renal function
* Penile anatomical defects and Peyronie's disease
* Diabetes mellitus Type I or insulin-dependent Type II
* Known prostate cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03917459
Study Brief:
Protocol Section:
NCT03917459