RecruitingPhase 2/3

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

United States1,276 participantsStarted 2025-06-27

Plain-language summary

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

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult male or female at least 50 years of age
✓. Has moderate CAVS as defined by:
✓. An AVA of ≥1.0 cm2 to ≤1.50 cm2
✓. An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men
✓. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
✓. 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

✕. 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)
✕. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
✕. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
✕. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
✕. New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
✕. Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
✕. Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
✕. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24

Timeframe: Week 24

(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48

Timeframe: Week 48

(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48

Timeframe: Week 48

NCT IDNCT07001800

SponsorKardigan, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-31

Kardigan Clinical Trial Information Team

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult male or female at least 50 years of age
✓. Has moderate CAVS as defined by:
✓. An AVA of ≥1.0 cm2 to ≤1.50 cm2
✓. An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men
✓. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
✓. 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

✕. 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)
✕. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
✕. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
✕. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
✕. New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
✕. Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
✕. Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
✕. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

What they're measuring

(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24

Timeframe: Week 24

(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48

Timeframe: Week 48

(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48

Timeframe: Week 48