Eligibility Module

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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 @ 5:01 AM
Ignite Modification Date: 2025-12-25 @ 5:01 AM
NCT ID: NCT05666518
Eligibility Criteria: Inclusion Criteria: vericiguat arm: * Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat) * Patients who gave written consent to this investigation control arm: * Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat) * Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization (This will be applied only for the first \~75% of patients meeting this criteria to be enrolled.) Note: No more than approximately 25% of patients without a qualifying history of prior heart failure hospitalization within 6 months or prior IV diuretics for heart failure not requiring hospitalization within 3 months can be enrolled in the study. * New York Heart Association (NYHA) Classification: Class II to Class IV * Left ventricular ejection fraction (LVEF): less than 45% * Patients who gave written informed consent to this study Exclusion Criteria: vericiguat arm: \- Patients who are participating in an interventional study control arm: * Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure * Patients who are participating in an interventional study
Healthy Volunteers: False
Sex: ALL
Study: NCT05666518
Study Brief:
Protocol Section: NCT05666518