CAVS (KATALYST-AV)

Study on Investigational Treatment for Calcific Aortic Valve Stenosis

Recruiting
50 years or above
All
Phase 2/3
1276 participants needed
1 Location

Brief description of study

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

Detailed description of study

This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Moderate Aortic Valve Stenosis
  • Age: 50 years or above
  • Gender: All

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

This study investigates calcific aortic valve stenosis. The purpose of this study is to evaluate if the investigational medication slows the progression of this condition in adults.

The study will focus on evaluating the safety, tolerability, and how the investigational medication is processed in the body. It will also look at its effects on heart valve function and oxygen use.

  • Who can participate: Adults aged 50 and older with moderate calcific aortic valve stenosis can participate. Key factors include specific measurements of heart valve function, such as aortic valve area and peak velocity, and a stable dose of beta blockers if applicable.
  • Study details: Participants will take part in assessments to monitor heart valve function and oxygen consumption. Some participants will receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 06 Jul 2026. Study ID: 25-0638

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