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

NCT07001800 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ATA-301
• Study Type: interventional
• Target: 1,276
• Locations: 2 countries
• Sites: 70

Brief Summary

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Conditions

Moderate Aortic Valve Stenosis

Keywords

Ataciguat; sGC activator; sGC stimulator; Aortic valve stenosis; Moderate aortic valve stenosis; Calcific aortic valve stenosis; CAVS; Moderate Calcific Aortic Valve Stenosis; Aortic Stenosis (AS)

Outcome Measures

Primary Outcomes (3)

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

  Week 24

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

  Week 48

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

  Week 48

Secondary Outcomes (8)

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

  Week 48

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

  Week 48

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

  Week 48

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

  Week 48

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

  Week 48

Study Arms (2)

Ataciguat

EXPERIMENTAL

Drug: Ataciguat

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ataciguat DRUG

Ataciguat will be administrated daily for up to 156 weeks

Ataciguat

Placebo DRUG

Placebo will be administrated daily for up to 156 weeks

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Kardigan, Inc.: lead

Study Sites (70)

University of Alabama at Birmingham (UAB) - Medical Center

Birmingham, Alabama, 35233, United States

RECRUITING

Heart Center Research LLC

Huntsville, Alabama, 35801, United States

RECRUITING

Onyx Clinical Research - Peoria

Peoria, Arizona, 85381, United States

NOT YET RECRUITING

Mayo Clinic - Phoenix

Phoenix, Arizona, 85259, United States

NOT YET RECRUITING

National Heart Institute

Beverly Hills, California, 90211, United States

RECRUITING

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Profound Research LLC at Southern California Heart Specialists

Pasadena, California, 91105, United States

RECRUITING

University of California, San Francisco (UCSF) - Medical Center

San Francisco, California, 94143, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

HCA Florida - JFK Hospital

Atlantis, Florida, 33462, United States

RECRUITING

New Generation of Medical Research

Hialeah, Florida, 33016, United States

RECRUITING

Memorial Healthcare System

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

New Generation of Medical Research - Naples

Naples, Florida, 34116, United States

RECRUITING

Flourish Research - St. Augustine

Saint Augustine, Florida, 32086, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

NOT YET RECRUITING

Northwestern University The Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute

Elk Grove Village, Illinois, 60007, United States

NOT YET RECRUITING

NorthShore University Health System

Glenview, Illinois, 60026, United States

RECRUITING

Riverside Medical Center - Illinois

Kankakee, Illinois, 60901, United States

NOT YET RECRUITING

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

NOT YET RECRUITING

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, 46514, United States

NOT YET RECRUITING

University of Louisville Health

Louisville, Kentucky, 40202, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Corewell Health

Royal Oak, Michigan, 48073, United States

RECRUITING

Henry Ford Hospital

West Bloomfield, Michigan, 48322, United States

RECRUITING

M Health Fairview St. John's Hospital

Maplewood, Minnesota, 55109, United States

NOT YET RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

NOT YET RECRUITING

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey, 08103, United States

NOT YET RECRUITING

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, 85831, United States

NOT YET RECRUITING

Inspira Medical Centers

Mullica Hill, New Jersey, 08062, United States

NOT YET RECRUITING

Inspira Medical Center of Vineland

Vineland, New Jersey, 08302, United States

NOT YET RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

University of Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University School of Medicine

Durham, North Carolina, 27710, United States

RECRUITING

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

Greensboro, North Carolina, 27401, United States

RECRUITING

Sanford Fargo

Fargo, North Dakota, 58122, United States

RECRUITING

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Bethesda North Hospital, TriHealth, Inc

Cincinnati, Ohio, 45242, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

NOT YET RECRUITING

Ascension St. John Hospital

Tulsa, Oklahoma, 74104, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

OnSite Clinical Solutions, LLC - Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

St. David's Heart and Vascular dba Austin Heart - Main Office

Austin, Texas, 78705, United States

RECRUITING

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

NOT YET RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

University of Texas Medical Branch - Galveston

Houston, Texas, 77555, United States

NOT YET RECRUITING

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

Methodist Hospital - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States

NOT YET RECRUITING

University of Utah Hospital & Clinics

Salt Lake City, Utah, 84112, United States

RECRUITING

St. Boniface Hospital

Winnipeg, Mantioba, R2H 2A6, Canada

NOT YET RECRUITING

Montreal Heart Institute - Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

NOT YET RECRUITING

Centre Hospitalier de l Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

NOT YET RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie De Quebec

Québec, Quebec, GIV 4G5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Kardigan Clinical Trial Information Team

CONTACT

1-877-310-5135; clinicaltrials@kardigan.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 3, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (66)