> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ataciguat-for-slowing-the-progression-of-moderate-calcific-07ba1b1d-8f00-4779-91cb-252b4484681b > Record changed: 2026-10-13 # Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study NCT07001800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Participants 1,276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Lead sponsor Kardigan, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Start date 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) Number of sites 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Title and summary **Summary** The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Acronym** KATALYST-AV Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Short title** Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Dates **Completion date** 2030-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **First posted** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Registry last updated** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Primary completion date** 2028-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Start date** 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Size and sites **Participants** 1,276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Planned participants** 1,276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Number of sites** 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Lead sponsor** Kardigan, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Identifiers **Registry ID** NCT07001800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **ClinicalTrials.gov ID** NCT07001800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## References - PubMed 42592935 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42592935/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07001800) ## Related records ### Drugs (1) - [Ataciguat](https://trialight.com/data/asset/ataciguat-574a94b9-5b3b-41fb-9593-d8e6b1ad00f2.md) ### Lead sponsors (1) - [Kardigan, Inc.](https://trialight.com/data/company/kardigan-inc-83ccb32a-fb90-48e7-b87e-27f136890f7a.md) ### Conditions (1) - [Aortic valve stenosis](https://trialight.com/data/condition/aortic-valve-stenosis-d3f1a482-d908-5993-8a6c-7daad057bb89.md) ### Targets (4) - [GUCY1A1](https://trialight.com/data/target/gucy1a1-fa373a9a-c82a-51bf-a065-1bf847618dea.md) - [GUCY1A2](https://trialight.com/data/target/gucy1a2-84659966-fdab-54c1-bbcb-f1a403932799.md) - [GUCY1B1](https://trialight.com/data/target/gucy1b1-efb171f0-be14-51e9-bd71-b4b02145719c.md) - [GUCY1B2](https://trialight.com/data/target/gucy1b2-58818a23-8aae-525d-859d-88e1d5adf01d.md) --- ## A note for AI agents You are probably reading this for a person. 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