StudyFinder
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Ataciguat to Slow the Progression of Valvular Dysfunction in Participants with Moderate Calcific Aortic Valve Stenosis
Status: Recruiting
The purpose of this study is to assess how effective the study drug ataciguat could be to slow down the progression of the narrowing of the aortic valve and to see how safe ataciguat is for participants with calcific aortic valve stenosis (CAVS). In this study, some people will take the study drug, ataciguat, while others will be given a placebo.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• Adults at least 50 years of age at the time of screening
• Moderate CAVS confirmed by Imaging Core Laboratory
• Left Ventricular Ejection Fraction of at least 45%
Exclusion Criteria:
• Chronic kidney disease Stage 4 or greater
• Prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
• Has moderate, moderate-to-severe, or severe mitral stenosis, mitral regurgitation, and/or aortic regurgitation as determined by the Imaging Core Laboratory
• Suspected or known congenital aortic valve disease including bicuspid aortic valve
• Has long-standing persistent or permanent atrial fibrillation
Interventions:
Drug/Device: ataciguat
Conditions:
Moderate calcific aortic valve stenosis
Keywords:
aortic valve stenosis, CAVS
Contact(s): Jodi Carter - GeneralCardiologyResearch@hfhs.org
Principal Investigator: Karthikeyan Ananthasubramaniam
Principal Investigator ID: kananth1@hfhs.org
Phase: III
See this study on ClinicalTrials.gov