Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Key facts
- Where
- Albany, Atlantis, Austin, Baltimore, Beverly Hills, Birmingham, Boston, Browns Mills, Buffalo, Camden, Chicago, Cincinnati, Cleveland, Dallas, Durham, Elk Grove Village, Elkhart, Fargo, Glenview, Greensboro, Hialeah, Hollywood, Houston, Huntsville, Jacksonville, Kankakee, Lancaster, Los Angeles, Louisville, Maplewood, Marietta, Miami, Moline, Morristown, Mullica Hill, Naperville, Naples, Nashville, Newburgh, Newport Beach, Pasadena, Peoria, Philadelphia, Phoenix, Pittsburgh, Plano, Portland, Rochester, Rock Hill, Royal Oak, Saint Augustine, Salt Lake City, San Antonio, San Francisco, Sarasota, St Louis, Sugar Land, Tampa, The Bronx, Toledo, Torrance, Tulsa, Vineland, and West Bloomfield, United StatesSee the 70 sites
- Phase
- Phase 2/3
Where in United States
- Albany Medical CenterAlbany, United StatesTaking people
- HCA Florida JFK HospitalAtlantis, United StatesTaking people
- St. David's Heart and Vascular dba Austin Heart - Main OfficeAustin, United StatesTaking people
- Johns Hopkins University School Of MedicineBaltimore, United StatesTaking people
- University of Maryland Medical CenterBaltimore, United StatesTaking people
- National Heart InstituteBeverly Hills, United StatesTaking people
- University of Alabama at Birmingham (UAB) - Medical CenterBirmingham, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Deborah Heart and Lung CenterBrowns Mills, United StatesNot yet recruiting
- University of BuffaloBuffalo, United StatesNo longer taking part
- Virtua Our Lady of Lourdes HospitalCamden, United StatesNot yet recruiting
- Northwestern University The Feinberg School of MedicineChicago, United StatesTaking people
- Bethesda North Hospital, TriHealth, IncCincinnati, United StatesNot yet recruiting
- The Lindner Center for Research and Education at The Christ HospitalCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Methodist Dallas Medical CenterDallas, United StatesNot yet recruiting
- Duke University School of MedicineDurham, United StatesTaking people
- Ascension Heart and Vascular/Alexian Brothers Heart & Vascular InstituteElk Grove Village, United StatesTaking people
- Midwest Cardiovascular Research and Education FoundationElkhart, United StatesTaking people
- Sanford FargoFargo, United StatesTaking people
- Northshore University Health SystemGlenview, United StatesTaking people
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone HealthGreensboro, United StatesTaking people
- New Generation of Medical ResearchHialeah, United StatesTaking people
- Memorial Healthcare SystemHollywood, United StatesNot yet recruiting
- Houston Methodist HospitalHouston, United StatesTaking people
- University of Texas Medical Branch - GalvestonHouston, United StatesNot yet recruiting
- Heart Center Research, LLCHuntsville, United StatesTaking people
- Jacksonville Center for Clinical ResearchJacksonville, United StatesTaking people
- Riverside Medical Center - IllinoisKankakee, United StatesNot yet recruiting
- Penn Medicine - Lancaster General HospitalLancaster, United StatesNot yet recruiting
- UCLA Ronald Reagan Medical CenterLos Angeles, United StatesNot yet recruiting
- University of Louisville HealthLouisville, United StatesTaking people
- M Health Fairview St. John's HospitalMaplewood, United StatesNot yet recruiting
- Wellstar Kennestone HospitalMarietta, United StatesNot yet recruiting
- University of MiamiMiami, United StatesNot yet recruiting
- Cardiovascular MedicineMoline, United StatesNot yet recruiting
- Atlantic Health System / Morristown Medical CenterMorristown, United StatesNot yet recruiting
- Inspira Medical CentersMullica Hill, United StatesNot yet recruiting
- Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- New Generation of Medical Research - NaplesNaples, United StatesTaking people
- TriStar Centennial Medical centerNashville, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- The Heart Hospital at Deaconess GatewayNewburgh, United StatesNot yet recruiting
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesTaking people
- Profound Research LLC at Southern California Heart SpecialistsPasadena, United StatesTaking people
- Methodist Medical Center of IllinoisPeoria, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Mayo Clinic PhoenixPhoenix, United StatesNot yet recruiting
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
- Baylor Scott and White - The Heart Hospital Baylor PlanoPlano, United StatesTaking people
- Providence St. Vincent Medical CenterPortland, United StatesNot yet recruiting
- Mayo Clinic - RochesterRochester, United StatesTaking people
- OnSite Clinical Solutions, LLC - Rock HillRock Hill, United StatesTaking people
- Corewell HealthRoyal Oak, United StatesTaking people
- Flourish Research - St. AugustineSaint Augustine, United StatesTaking people
- University of Utah Hospital & ClinicsSalt Lake City, United StatesTaking people
- Methodist Hospital San AntonioSan Antonio, United StatesTaking people
- University of California San Francisco - UCSF Medical CenterSan Francisco, United StatesTaking people
- Sarasota Memorial HospitalSarasota, United StatesTaking people
- Missouri Baptist Medical CenterSt Louis, United StatesNot yet recruiting
- Washington UniversitySt Louis, United StatesTaking people
- Houston Methodist Sugar Land HospitalSugar Land, United StatesNot yet recruiting
- University of South FloridaTampa, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- ProMedica Toledo HospitalToledo, United StatesNot yet recruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesTaking people
- Ascension St. John HospitalTulsa, United StatesTaking people
- Inspira Medical Center of VinelandVineland, United StatesNot yet recruiting
- Henry Ford HospitalWest Bloomfield, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kardigan, Inc.
- Trial code
- NCT07001800EU 2025-522176-86-01
- Record updated
- 6 July 2026
- Original description
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.Read full original descriptionShow less
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
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Inclusion: Adult male or female at least 50 years of age; Has moderate CAVS as defined by:; An AVA of ≥1.0 cm2 to ≤1.50 cm2; An AVC score between >300 to 1200 Agatston units (AU) for women and between >300 to 2000 AU for men; Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory; 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.
Exclusion: Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months; 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); Has suspected or known congenital aortic valve disease including bicuspid aortic valve; New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes; Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid; Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery; Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation; Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation.