What this study is
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
What's being tested
- Ataciguat
Intervention · DRUG
Ataciguat will be administrated daily for up to 156 weeks
- Placebo
Intervention · DRUG
Placebo will be administrated daily for up to 156 weeks
Study details
- 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
- Sponsor
- Kardigan, Inc.
- Conditions
- Moderate Aortic Valve Stenosis
- Enrolling
- 1,276 people
- Starts
- 2025-06-27
- Est. completion
- 2030-09-30
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
- Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention 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
- 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
- Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (74)
73 openContact for every open site
- Kardigan Clinical Study Information Team · Contact1-877-310-5135clinicaltrials@kardigan.bio
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, United States
RecruitingHeart Center Research LLC
Huntsville, Alabama, United States
RecruitingMayo Clinic - Phoenix
Phoenix, Arizona, United States
Not yet recruitingNational Heart Institute
Beverly Hills, California, United States
RecruitingUCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Not yet recruitingHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RecruitingProfound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
RecruitingUniversity of California, San Francisco (UCSF) - Medical Center
San Francisco, California, United States
RecruitingLundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
RecruitingHCA Florida - JFK Hospital
Atlantis, Florida, United States
RecruitingNew Generation of Medical Research
Hialeah, Florida, United States
RecruitingMemorial Healthcare System
Hollywood, Florida, United States
Not yet recruitingJacksonville Center for Clinical Research
Jacksonville, Florida, United States
RecruitingUniversity of Miami
Miami, Florida, United States
Not yet recruitingNew Generation of Medical Research - Naples
Naples, Florida, United States
RecruitingFlourish Research - St. Augustine
Saint Augustine, Florida, United States
RecruitingSarasota Memorial Hospital
Sarasota, Florida, United States
RecruitingUniversity of South Florida
Tampa, Florida, United States
RecruitingWellstar Kennestone Hospital
Marietta, Georgia, United States
Not yet recruitingNorthwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
RecruitingAscension Heart and Vascular/Alexian Brothers Heart & Vascular Institute
Elk Grove Village, Illinois, United States
RecruitingNorthShore University Health System
Glenview, Illinois, United States
RecruitingRiverside Medical Center - Illinois
Kankakee, Illinois, United States
Not yet recruitingCardiovascular Medicine
Moline, Illinois, United States
Not yet recruitingMidwest Cardiovascular Institute
Naperville, Illinois, United States
RecruitingMethodist Medical Center of Illinois
Peoria, Illinois, United States
RecruitingMidwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
RecruitingThe Heart Hospital at Deaconess Gateway
Newburgh, Indiana, United States
Not yet recruitingUniversity of Louisville Health
Louisville, Kentucky, United States
RecruitingUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RecruitingJohns Hopkins University School of Medicine
Baltimore, Maryland, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
RecruitingCorewell Health
Royal Oak, Michigan, United States
RecruitingHenry Ford Hospital
West Bloomfield, Michigan, United States
RecruitingM Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
Not yet recruitingMayo Clinic - Rochester
Rochester, Minnesota, United States
RecruitingWashington University
St Louis, Missouri, United States
RecruitingMissouri Baptist Medical Center
St Louis, Missouri, United States
Not yet recruitingDeborah Heart and Lung Center
Browns Mills, New Jersey, United States
Not yet recruitingVirtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States
Not yet recruitingAtlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States
Not yet recruitingInspira Medical Centers
Mullica Hill, New Jersey, United States
Not yet recruitingInspira Medical Center of Vineland
Vineland, New Jersey, United States
Not yet recruitingAlbany Medical Center
Albany, New York, United States
RecruitingMontefiore Medical Center
The Bronx, New York, United States
RecruitingDuke University School of Medicine
Durham, North Carolina, United States
RecruitingMoses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
RecruitingSanford Fargo
Fargo, North Dakota, United States
RecruitingThe Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
RecruitingBethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio, United States
Not yet recruitingCleveland Clinic
Cleveland, Ohio, United States
RecruitingProMedica Toledo Hospital
Toledo, Ohio, United States
Not yet recruitingAscension St. John Hospital
Tulsa, Oklahoma, United States
RecruitingProvidence St. Vincent Medical Center
Portland, Oregon, United States
Not yet recruitingPenn Medicine Lancaster General Hospital
Lancaster, Pennsylvania, United States
Not yet recruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RecruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RecruitingOnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, South Carolina, United States
RecruitingTriStar Centennial Medical Center
Nashville, Tennessee, United States
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
RecruitingSt. David's Heart and Vascular dba Austin Heart - Main Office
Austin, Texas, United States
RecruitingMethodist Dallas Medical Center
Dallas, Texas, United States
Not yet recruitingHouston Methodist Hospital
Houston, Texas, United States
RecruitingUniversity of Texas Medical Branch - Galveston
Houston, Texas, United States
Not yet recruitingBaylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, United States
RecruitingMethodist Hospital - San Antonio
San Antonio, Texas, United States
RecruitingHouston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Not yet recruitingUniversity of Utah Hospital & Clinics
Salt Lake City, Utah, United States
RecruitingUniversity of Buffalo
Buffalo, New York, United States
Withdrawn
4 sites outside the US
St. Boniface Hospital
Winnipeg, Mantioba, Canada
Not yet recruitingMontreal Heart Institute - Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
RecruitingCentre Hospitalier de l Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Not yet recruitingInstitut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, Canada
Recruiting
Study team
Sponsor
Kardigan, Inc.
Study ID ATA-301
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.