2025-522176-86-01RecruitingPhase 3
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 (KATALYST-AV)
Kardigan Inc.47 sites in 7 countries496 target enrollmentStarted: October 1, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 496
- Locations
- 47
Study Overview
Brief Summary
Part B: To determine whether ataciguat slows the rate of AVA loss Part B: To evaluate the effect of ataciguat on peak VO2
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult male or female at least 50 years of age
- •Has moderate CAVS as defined by: a) An AVA of ≥1.0 cm2 to ≤1.50 cm2 b) An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men on non-contrast CT
- •Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the Imaging Core Laboratory
- •For participants 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
- •Additional criteria as listed in the protocol may apply
Exclusion Criteria
- •Has a prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
- •Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- •Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- •Has New York Heart Association (NYHA) Class III or Class IV heart failure symptoms
- •Has a primary etiology for heart failure other than aortic valve disease
- •Has coronary artery disease or anticipating coronary stenting surgery
- •Has an average QTcF ≥480 msec at Screening according to the Investigator’s assessment, risk factors for torsades de pointes, such as hypokalemia, a family history of long QT syndrome, or concurrent use of medications that prolong the QT/QTc interval, abnormal electrocardiogram (ECG) results and/or long-standing persistent or permanent atrial fibrillation
- •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 (e.g. pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
- •Additional criteria as listed in the protocol may apply
Arms & Interventions
Placebo to match IMP/ataciguat
Placebo
Intervention: Placebo to match IMP/ataciguat (Drug)
Ataciguat
Test
Intervention: Ataciguat (Drug)
Investigators
SM Kardigan Medical Information
Scientific
Kardigan Inc.
Study Sites (47)
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