Status:
RECRUITING
A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis
Lead Sponsor:
Kardigan, Inc.
Conditions:
Moderate Aortic Valve Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Detailed 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 and whether the c...
Eligibility Criteria
Inclusion
- Key
- Adult male or female at least 50 years of age
- Has moderate CAVS as defined by:
- An AVA of ≥1 cm2 to ≤1.50 cm2
- An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men
- Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Core Laboratory
- Can perform Cardiopulmonary Exercise Testing (CPET)
- Key
Exclusion
- Has had a prior aortic valve replacement, repair, surgery, or intervention
- Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- Has known congenital aortic valve disease including bicuspid aortic valve
- New York Heart Association (NYHA) Class III or Class IV
- Has heart failure such as cardiomyopathy, congenital heart disease, myocarditis
- Has coronary artery disease or anticipating coronary stenting surgery
- Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
1410 Patients enrolled
Trial Details
Trial ID
NCT07001800
Start Date
June 27 2025
End Date
September 30 2030
Last Update
September 11 2025
Active Locations (47)
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1
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, United States, 35233
2
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
3
National Heart Institute
Beverly Hills, California, United States, 90211
4
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663