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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT05658458
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants aged ≥18 years at the time point of signing ICF
* Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation
* Has chronic HF with reduced LVEF (\<45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF \[without hospitalization\])
* Is capable of giving signed ICF and willing to comply with the study-related procedures
* Female participants in the following categories:
* A female who is not of reproductive potential, defined as a female who either: (a) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (b) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening; or (c) has a congenital or acquired condition that prevents childbearing
* A female who is of reproductive potential and agrees to avoid becoming pregnant while receiving the study drug and for 14 days after the last dose of the study drug by complying with one of the following: (a) practice abstinence from heterosexual activity or (b) use (and have her partner use) acceptable, highly effective contraception methods during heterosexual activity.
Exclusion Criteria:
* Is clinically unstable at the time of screening defined by:
* Administration of any iv treatment within 24 hours until start of study intervention, and/or
* SBP \< 100 mmHg or symptomatic hypotension.
* Has concurrent or anticipated use of PDE5 inhibitors, or a sGC stimulator such as riociguat.
* Has known allergy or hypersensitivity to any sGC stimulator.
* Has severe hepatic insufficiency such as with hepatic encephalopathy.
* Has severe renal impairment with eGFR \< 15 mL/min/1.73m\*2 (calculated based on the MDRD equation) or on dialysis.
* Is pregnant or breast feeding or plans to become pregnant or to breastfeed during the course of the trial.
* Participated in another interventional clinical study and treatment with another investigational product ≤ 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05658458
Study Brief:
Protocol Section:
NCT05658458