Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

NCT07001800
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Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
1,276
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Lead sponsor
Kardigan, Inc.
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Start date
2025-06-27
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Number of sites
74
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Summary
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
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Acronym
KATALYST-AV
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Short title
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
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Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2030-09-30
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First posted
2025-06-03
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Registry last updated
2026-07-06
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Primary completion date
2028-08-31
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Start date
2025-06-27
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Participants
1,276
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Participant count basis
Estimated
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Planned participants
1,276
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Protocol amendments
3
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Number of sites
74
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Kardigan, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07001800
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ClinicalTrials.gov ID
NCT07001800
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. (Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24

    Timeframe: Week 24

  2. (Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48

    Timeframe: Week 48

  3. (Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48

    Timeframe: Week 48

  1. (Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48

    Timeframe: Week 48

  2. (Part A) Change in VO2 from baseline to Week 48

    Timeframe: Week 48

  3. Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48

    Timeframe: Week 48

  4. (Part A) Change in Left Ventricular Mass Index (LVMI) from baseline to Week 48

    Timeframe: Week 48

  5. (Part A) Change in Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) from baseline to Week 48

    Timeframe: Week 48

    KCCQ-23 is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score.

  6. (Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48

    Timeframe: Week 48

  7. (Part B) Time to decision to proceed with TAVR/SAVR or all-cause death

    Timeframe: Week 158

  8. (Part B) Percentage of participants with progression to AVA <1.0cm2 at Week 48

    Timeframe: Week 48

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
No

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
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at Birmingham (UAB) - Medical CenterBirmingham, United StatesRecruiting
  • Heart Center Research LLCHuntsville, United StatesRecruiting
  • Mayo Clinic - PhoenixPhoenix, United StatesNot yet recruiting
  • National Heart InstituteBeverly Hills, United StatesRecruiting
  • UCLA Ronald Reagan Medical CenterLos Angeles, United StatesNot yet recruiting
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting
  • Profound Research LLC at Southern California Heart SpecialistsPasadena, United StatesRecruiting
  • University of California, San Francisco (UCSF) - Medical CenterSan Francisco, United StatesRecruiting
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorrance, United StatesRecruiting
  • HCA Florida - JFK HospitalAtlantis, United StatesRecruiting
  • New Generation of Medical ResearchHialeah, United StatesRecruiting
  • Memorial Healthcare SystemHollywood, United StatesNot yet recruiting
  • Jacksonville Center for Clinical ResearchJacksonville, United StatesRecruiting
  • University of MiamiMiami, United StatesNot yet recruiting
  • New Generation of Medical Research - NaplesNaples, United StatesRecruiting
  • Flourish Research - St. AugustineSaint Augustine, United StatesRecruiting
  • Sarasota Memorial HospitalSarasota, United StatesRecruiting
  • University of South FloridaTampa, United StatesRecruiting
  • Wellstar Kennestone HospitalMarietta, United StatesNot yet recruiting
  • Northwestern University The Feinberg School of MedicineChicago, United StatesRecruiting
  • Ascension Heart and Vascular/Alexian Brothers Heart & Vascular InstituteElk Grove Village, United StatesRecruiting
  • NorthShore University Health SystemGlenview, United StatesRecruiting
  • Riverside Medical Center - IllinoisKankakee, United StatesNot yet recruiting
  • Cardiovascular MedicineMoline, United StatesNot yet recruiting
  • Midwest Cardiovascular InstituteNaperville, United StatesRecruiting

And 49 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (4)