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This study evaluates the effect of the drug Vericiguat, added to guideline-directed standard therapy (GDMT), on reverse remodeling indices of the heart in people with heart failure with reduced ejection fraction (HFrEF). Adults aged 18 and over with stable HFrEF who have been on standard therapy for at least 3 months may take part. The study is in Phase 4 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study, * Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic treatment, * Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%, confirmed by echocardiography) within 12 months before randomization, * Stable GDMT for HFrEF for at least 3 months prior to randomisation. Exclusion Criteria: * Systolic blood pressure \< 100 mmHg or symptomatic hypotension, * Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors, * Known allergy/hypersensitivity to soluble guanylate cyclase stimulators, * Awaiting heart transplantation or dependence on continuous inotropic therapy * Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy, * Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation, * Long-term mechanical circulatory support of the left ventricle, * Active infection, * Chronic kidney disease stage 4 or 5, and * Advanced liver failure classified as Child-Pugh B or C.