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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 22, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07405944). This is a study registration, not published results. Lead sponsor: University Medical Centre Ljubljana. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF), Chronic Heart Failure. Interventions: DRUG: Vericiguat; DRUG: Guideline Directed Medical Therapy for Heart Failure (GDMT). Primary outcome measures: Change in right ventricular systolic function assessed by right ventricular fractional area change (RV FAC) , Baseline to 6 months and 12 months. Brief summary: The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy. The main questions are: * Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)? * Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance? * Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months. Participants will: * Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing * Perform oral glucose tolerance tests (OGTT) to assess insulin resistance * Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion * Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.