A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis (KATALYST-AV)

Kardigan, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Moderate Aortic Valve Stenosis

Treatments: Drug: Placebo; Drug: Ataciguat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07001800

ATA-301

Details and patient eligibility

About

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

Full description

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 and whether the change in AVC effects peak oxygen consumption (pVO2) in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. The purpose of Part B is to evaluate the effect of ataciguat on peak VO2 and to investigate whether ataciguat reduces the rate of aortic valve area (AVA) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated.

Enrollment: 1,410 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 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:

1. 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 electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,410 participants in 2 patient groups, including a placebo group

Ataciguat

Experimental group

Treatment:

Drug: Ataciguat

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo