A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis
Kardigan, Inc.
Summary
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Description
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 ataci…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Adult male or female at least 50 years of age 2. Has moderate CAVS as defined by: 1. An AVA of ≥1.0 cm2 to ≤1.50 cm2 2. An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory 4. For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated chan…
Interventions
- DrugAtaciguat
Ataciguat will be administrated daily for up to 156 weeks
- DrugPlacebo
Placebo will be administrated daily for up to 156 weeks
Locations (70)
- University of Alabama at Birmingham (UAB) - Medical CenterBirmingham, Alabama
- Heart Center Research LLCHuntsville, Alabama
- Onyx Clinical Research - PeoriaPeoria, Arizona
- Mayo Clinic - PhoenixPhoenix, Arizona
- National Heart InstituteBeverly Hills, California
- UCLA Ronald Reagan Medical CenterLos Angeles, California