NCT07001800 · Kardigan, Inc.
A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis
(KATALYST-AV)
What this study is about
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
View original scientific description
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Interventions
DRUG
Ataciguat
Ataciguat will be administrated daily for up to 156 weeks
DRUG
Placebo
Placebo will be administrated daily for up to 156 weeks
Primary outcome measures
(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24
Time frame: Week 24
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48
Time frame: Week 48
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48
Time frame: Week 48
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult male or female at least 50 years of age 2. Has moderate CAVS as defined by: 1. An AVA of ≥1 cm2 to ≤1.50 cm2 2. An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 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 Core Laboratory 4. Can perform Cardiopulmonary Exercise Testing (CPET) Key
Exclusion criteria
- Has had a prior aortic valve replacement, repair, surgery, or intervention 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation 3. Has known congenital aortic valve disease including bicuspid aortic valve 4. New York Heart Association (NYHA) Class III or Class IV 5. Has heart failure such as cardiomyopathy, congenital heart disease, myocarditis 6. Has coronary artery disease or anticipating coronary stenting surgery 7. Abnormal electrocardiog
Where
- Birmingham, Alabama
- Huntsville, Alabama
- Phoenix, Arizona
- Beverly Hills, California
- Los Angeles, California
- Newport Beach, California
- Pasadena, California
- San Francisco, California
- Torrance, California
- Atlantis, Florida
- Hialeah, Florida
- Hollywood, Florida
And 52 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations