Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: 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 ≥600 to 1200 Agatston units (AU) for women and between ≥600 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 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 Who Should NOT Join This Trial: 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 III or Class IV 6. Has a primary etiology for heart failure other than aortic valve disease 7. Has coronary artery disease or anticipating coronary stenting surgery 8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 ≥600 to 1200 Agatston units (AU) for women and between ≥600 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 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 III or Class IV 6. Has a primary etiology for heart failure other than aortic valve disease 7. Has coronary artery disease or anticipating coronary stenting surgery 8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Treatments Being Tested

DRUG

Ataciguat

Ataciguat will be administrated daily for up to 156 weeks

DRUG

Placebo

Placebo will be administrated daily for up to 156 weeks

Locations (20)

University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, United States
Heart Center Research LLC
Huntsville, Alabama, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
University of California, San Francisco (UCSF) - Medical Center
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
HCA Florida - JFK Hospital
Atlantis, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
New Generation of Medical Research - Naples
Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
NorthShore University Health System
Glenview, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States