Study of Ataciguat to Slow Progression of Moderate Calcific Aortic Valve Stenosis in Adults Aged 50 and Older

What this Trial Is About

Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis CAVS in adults aged 50 and older. This study is conducted in two parts Part A focuses on whether ataciguat reduces calcium buildup in the aortic valve over 24 weeks, while Part B examines if the drug slows narrowing of the valve area and improves peak oxygen consumption over 48 weeks. Safety, tolerability, and how the body processes ataciguat are also assessed. Participants receive either ataciguat or a placebo daily for up to 156 weeks. Part A enrolls about 132 participants, and Part B will begin after Part A completes, enrolling around 1144 participants. Part B includes additional evaluation of heart function and ability to exercise. The study uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants undergo imaging tests like CT scans and echocardiograms to measure valve calcium and valve area. Cardiopulmonary exercise testing CPET is used to assess peak oxygen consumption. Researchers also monitor heart function, symptoms, and quality of life using questionnaires. Assessments occur mainly at baseline, Week 24, and Week 48, with long-term follow-up to 156 weeks for safety and efficacy. The studys total duration extends to 2030.

Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study