Study of Vericiguat Added to Standard Heart Failure Therapy to Improve Heart Function and Structure in Adults with Stable Heart Failure and Reduced Ejection Fraction

What this Trial Is About

Researchers are evaluating how vericiguat affects adults with stable heart failure with reduced ejection fraction HFrEF who are already receiving guideline-directed medical therapy GDMT. The study aims to determine whether vericiguat improves right ventricular systolic function measured by tricuspid annular plane systolic excursion TAPSE and how it influences myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance. The study will also explore how genetic and oxidative stress profiles may impact the treatment response. Sixty participants will be randomly assigned to receive either vericiguat plus usual care or usual care alone for 12 months. Vericiguat will be given orally, starting at 2.5 mg once daily and gradually increased every two weeks to a target dose of 10 mg as tolerated. Blood samples, oral glucose tolerance tests, echocardiography, cardiac MRI, and scintigraphy will be performed at baseline and follow-up visits at 1, 3, 6, and 12 months. After the 12-month randomized phase, participants in the usual care group will be offered open-label vericiguat and followed for another 12 months to reassess outcomes. During the study, participants will have blood drawn for biomarker, genetic, metabolomic, transcriptomic, and hematologic analyses, including platelet function testing. Imaging will assess heart structure and function, including volumes, fibrosis, and perfusion. Researchers will measure changes in right ventricular function as the primary outcome and evaluate secondary outcomes such as left ventricular function, fibrosis, inflammation, angiogenesis, insulin sensitivity, and kidney function. The total study duration may last up to 24 months for some participants, including the exploratory extension phase.

Vericiguat and Reverse Remodeling Indices in Heart Failure