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Recruiting Phase 2/3

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

NCT07001800 · tracked via the Priya Life Science USA tracker
Phase
Phase 2/3
Started
2025-06-27
Last updated
2026-07-06

Condition(s) studied

Moderate Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

AtaciguatPlacebo

Ataciguat: Ataciguat will be administrated daily for up to 156 weeks

Placebo: Placebo will be administrated daily for up to 156 weeks

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
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

Primary outcome measure(s)

  • (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

Trial sites (74)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) - Medical Center Birmingham Alabama Recruiting
Heart Center Research LLC Huntsville Alabama Recruiting
Mayo Clinic - Phoenix Phoenix Arizona Not Yet Recruiting
National Heart Institute Beverly Hills California Recruiting
UCLA Ronald Reagan Medical Center Los Angeles California Not Yet Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Profound Research LLC at Southern California Heart Specialists Pasadena California Recruiting
University of California, San Francisco (UCSF) - Medical Center San Francisco California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center Torrance California Recruiting
HCA Florida - JFK Hospital Atlantis Florida Recruiting
New Generation of Medical Research Hialeah Florida Recruiting
Memorial Healthcare System Hollywood Florida Not Yet Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
University of Miami Miami Florida Not Yet Recruiting
New Generation of Medical Research - Naples Naples Florida Recruiting
Flourish Research - St. Augustine Saint Augustine Florida Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
University of South Florida Tampa Florida Recruiting
Wellstar Kennestone Hospital Marietta Georgia Not Yet Recruiting
Northwestern University The Feinberg School of Medicine Chicago Illinois Recruiting
Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute Elk Grove Village Illinois Recruiting
NorthShore University Health System Glenview Illinois Recruiting
Riverside Medical Center - Illinois Kankakee Illinois Not Yet Recruiting
Cardiovascular Medicine Moline Illinois Not Yet Recruiting
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Methodist Medical Center of Illinois Peoria Illinois Recruiting
Midwest Cardiovascular Research and Education Foundation Elkhart Indiana Recruiting
The Heart Hospital at Deaconess Gateway Newburgh Indiana Not Yet Recruiting
University of Louisville Health Louisville Kentucky Recruiting
University of Maryland Medical Center Baltimore Maryland Recruiting
Johns Hopkins University School of Medicine Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Corewell Health Royal Oak Michigan Recruiting
Henry Ford Hospital West Bloomfield Michigan Recruiting
M Health Fairview St. John's Hospital Maplewood Minnesota Not Yet Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Washington University St Louis Missouri Recruiting
Missouri Baptist Medical Center St Louis Missouri Not Yet Recruiting
Deborah Heart and Lung Center Browns Mills New Jersey Not Yet Recruiting

+ 34 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07001800 on ClinicalTrials.gov ↗ ← All trials in the USA