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Ataciguat to slow progression of moderate calcific aortic valve stenosis

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

Phase2; Phase3 Interventional Kardigan, Inc. · NCT07001800

This trial will test whether ataciguat can slow valve calcium buildup and disease progression in adults with moderate aortic valve stenosis.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1276 (estimated)
Ages50 Years and up
SexAll
SponsorKardigan, Inc. Industry-sponsored
Locations70 sites (Birmingham, Alabama and 69 other locations)
Trial IDNCT07001800 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2/3 study gives adults with moderate calcific aortic valve stenosis either ataciguat or placebo and follows them for changes in valve disease. Part A (about 132 participants) focuses on whether ataciguat slows aortic valve calcium (AVC) deposition and collects safety and pharmacokinetic data, including a CPET sub-study for some participants. Part B (about 1,144 participants) begins after Part A and examines whether ataciguat slows aortic valve area (AVA) loss and affects peak oxygen consumption (VO2), while continuing to monitor safety and tolerability. Key entry criteria include age ≥50, AVA 1.0–1.5 cm2, specified Agatston AVC score ranges by sex, and left ventricular ejection fraction ≥45%.

Who should consider this trial

Good fit: Adults aged 50 or older with moderate calcific aortic valve stenosis (AVA 1.0–1.5 cm2), an Agatston AVC score within the protocol-specified ranges by sex, and left ventricular ejection fraction ≥45% are the intended participants.

Not a fit: Patients with severe aortic stenosis, prior valve replacement, left ventricular ejection fraction below 45%, or medical conditions that prevent completing protocol procedures such as CPET are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, ataciguat could slow valve calcification and disease progression, potentially delaying the need for valve intervention and preserving exercise capacity.

How similar studies have performed: sGC activators and stimulators have shown promise in preclinical work and early cardiovascular studies but have not yet been proven to slow aortic valve calcification in large clinical trials, so this approach is relatively novel for aortic stenosis.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate Aortic Valve StenosisAtaciguatsGC activatorsGC stimulatorAortic valve stenosisModerate aortic valve stenosisCalcific aortic valve stenosisCAVS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.