Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Start Date
6/27/2025
Completion Date
9/30/2030
Summary
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Detailed Description
This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
Ataciguat
Placebo
Conditions
Locations
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama 35233
United States
Heart Center Research LLC
Huntsville, Alabama 35801
United States
Mayo Clinic - Phoenix
Phoenix, Arizona 85259
United States
National Heart Institute
Beverly Hills, California 90211
United States
UCLA Ronald Reagan Medical Center
Los Angeles, California 90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Profound Research LLC at Southern California Heart Specialists
Pasadena, California 91105
United States
University of California, San Francisco (UCSF) - Medical Center
San Francisco, California 94143
United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California 90502
United States
HCA Florida - JFK Hospital
Atlantis, Florida 33462
United States
New Generation of Medical Research
Hialeah, Florida 33016
United States
Memorial Healthcare System
Hollywood, Florida 33021
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United States
University of Miami
Miami, Florida 33136
United States
New Generation of Medical Research - Naples
Naples, Florida 34116
United States
Flourish Research - St. Augustine
Saint Augustine, Florida 32086
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
University of South Florida
Tampa, Florida 33606
United States
Wellstar Kennestone Hospital
Marietta, Georgia 30060
United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois 60611
United States
Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute
Elk Grove Village, Illinois 60007
United States
NorthShore University Health System
Glenview, Illinois 60026
United States
Riverside Medical Center - Illinois
Kankakee, Illinois 60901
United States
Cardiovascular Medicine
Moline, Illinois 61265
United States
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United States
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana 46514
United States
The Heart Hospital at Deaconess Gateway
Newburgh, Indiana 47630
United States
University of Louisville Health
Louisville, Kentucky 40202
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Corewell Health
Royal Oak, Michigan 48073
United States
Henry Ford Hospital
West Bloomfield, Michigan 48322
United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota 55109
United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United States
Washington University
St Louis, Missouri 63110
United States
Missouri Baptist Medical Center
St Louis, Missouri 63131
United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015
United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey 08103
United States
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey 85831
United States
Inspira Medical Centers
Mullica Hill, New Jersey 08062
United States
Inspira Medical Center of Vineland
Vineland, New Jersey 08302
United States
Albany Medical Center
Albany, New York 12208
United States
University of Buffalo
Buffalo, New York 14203
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Duke University School of Medicine
Durham, North Carolina 27710
United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina 27401
United States
Sanford Fargo
Fargo, North Dakota 58122
United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
United States
Bethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio 45242
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
ProMedica Toledo Hospital
Toledo, Ohio 43606
United States
Ascension St. John Hospital
Tulsa, Oklahoma 74104
United States
Providence St. Vincent Medical Center
Portland, Oregon 97225
United States
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania 17602
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
OnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, South Carolina 29732
United States
TriStar Centennial Medical Center
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
St. David's Heart and Vascular dba Austin Heart - Main Office
Austin, Texas 78705
United States
Methodist Dallas Medical Center
Dallas, Texas 75203
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Texas Medical Branch - Galveston
Houston, Texas 77555
United States
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas 75093
United States
Methodist Hospital - San Antonio
San Antonio, Texas 78229
United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas 77479
United States
University of Utah Hospital & Clinics
Salt Lake City, Utah 84112
United States
St. Boniface Hospital
Winnipeg, Mantioba R2H 2A6
Canada
Montreal Heart Institute - Institut de Cardiologie de Montreal
Montreal, Quebec H1T 1C8
Canada
Centre Hospitalier de l Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec GIV 4G5
Canada