Clinical Trials

    Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV)

    Investigator: Sachin Goel

    Study Coordinator: Sejal Dave

    Status: Enrolling

    ClinicalTrials.gov Number: NCT07001800

    Phone: 281.654.5383

    Protocol Number: PRO00040862

    Description


    The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults. This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.