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

NCT07001800

RecruitingPhase 2, Phase 3

Sponsor: Kardigan, Inc.

Conditions: Moderate Aortic Valve Stenosis

Interventions: Ataciguat, Placebo

Countries: United States, Canada

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 changes during the study

Key Exclusion Criteria:

1. For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
2. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
3. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
4. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
5. New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
6. Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
7. Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Locations (74)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Pasadena, California, United States
San Francisco, California, United States
Torrance, California, United States
Atlantis, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Saint Augustine, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Glenview, Illinois, United States
Kankakee, Illinois, United States
Moline, Illinois, United States
Naperville, Illinois, United States
Peoria, Illinois, United States
Elkhart, Indiana, United States
Newburgh, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
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