Ataciguat to slow progression of moderate calcific aortic valve stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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%.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham (UAB) - Medical Center
  Birmingham, Alabama, United States Recruiting
• Heart Center Research LLC
  Huntsville, Alabama, United States Recruiting
• National Heart Institute
  Beverly Hills, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Profound Research LLC at Southern California Heart Specialists
  Pasadena, California, United States Recruiting
• University of California, San Francisco (UCSF) - Medical Center
  San Francisco, California, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Kardigan Clinical Trial Information Team
• Email: clinicaltrials@kardigan.bio
• Phone: 1-877-310-5135

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observing the progression of moderate aortic valve disease

  This study looks at how moderate aortic valve disease gets worse over time to help doctors understand what affects its progression and how treatments might help patients.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT06595992

• Evaluating treatment options for aortic valve stenosis

  This study is testing how different treatments for aortic valve stenosis, like surgery and other options, affect patients' quality of life and survival.

  Recruiting St. Antonius Hospital · Nieuwegein · NCT06168123

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.