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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT05728502
Eligibility Criteria:
Inclusion Criteria:
vericiguat arm
* Female and male patients ≥ 18 years of age who are naïve to vericiguat treatment
* Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
* Decision to initiate treatment with vericiguat as per the local approved label
* Signed informed consent
control arm
* Aged 18 or over at baseline
* Only patients receiving SoC for chronic heart failure (no history of receiving vericiguat prior to the index date)
* Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
Exclusion Criteria:
vericiguat arm
* Participation in other investigational program with interventions outside of routine clinical practice
* Contra-indications according to the local marketing authorization label
control arm
* Patients who have started therapy with vericiguat for chronic heart failure at baseline
* Contra-indications according to the vericiguat local marketing authorization label
* Patients participating in an interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05728502
Study Brief:
Protocol Section:
NCT05728502