Actively Recruiting
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
Led by Kardigan, Inc. · Updated on 2026-05-06
1276
Participants Needed
70
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis (CAVS) in adults aged 50 and older. The study is conducted in two parts: Part A focuses on whether ataciguat reduces the buildup of calcium in the aortic valve, while Part B assesses if it slows the loss of aortic valve area and improves peak oxygen consumption. The safety, tolerability, and how the body processes ataciguat are also being studied. Participants will receive either ataciguat or a placebo daily for up to 156 weeks. Part A will enroll about 132 participants to study calcium changes over 24 weeks, and Part B will enroll approximately 1144 participants to observe valve area and exercise capacity over 48 weeks. The study uses random assignment and participants and researchers will not know who receives ataciguat or placebo. Throughout the study, participants will undergo imaging scans like non-contrast CT and echocardiograms, exercise tests to measure peak oxygen consumption, and questionnaires about heart-related quality of life. Researchers will monitor heart function, valve calcium, and symptoms at baseline and follow-up visits up to about three years. Safety and any side effects will be carefully tracked during this time.
CONDITIONS
Brief Title
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female at least 50 years of age
- Diagnosed with moderate calcific aortic valve stenosis defined by an aortic valve area (AVA) from 1.0 cm2 to 1.50 cm2
- Aortic valve calcium (AVC) score between >300 to 1200 Agatston units for women and >300 to 2000 Agatston units for men
- Left ventricular ejection fraction of 45% or higher at screening
- If on beta blockers (for Part A CPET sub-study and all Part B participants), dose must be stable for at least 90 days before screening with no planned changes during the study
You will not qualify if you...
- Medical or physical conditions that prevent completing exercise testing procedures (e.g., lung disease, joint or leg problems, or other contraindications)
- Planned or anticipated aortic valve replacement, repair, surgery, or intervention within the next 6 months
- Moderate to severe mitral valve conditions or aortic regurgitation
- Known or suspected congenital aortic valve disease including bicuspid valve
- New York Heart Association Class IV heart failure symptoms or need for continuous inotropic support
- History of hypertrophic, genetic, familial cardiomyopathy, or cardiomyopathy related to amyloid or sarcoid
- Untreated obstructive coronary artery disease or planned coronary stenting
- Abnormal electrocardiogram results or persistent atrial fibrillation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 156 weeks
Participants receive daily administration of ataciguat or placebo for up to 156 weeks to evaluate the effect on slowing the progression of moderate calcific aortic valve stenosis.
Regular visits for monitoring and assessments during treatment (visit schedule as per protocol)
Trial Site Locations
Total: 70 locations
1
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
Actively Recruiting
3
Onyx Clinical Research - Peoria
Peoria, Arizona, United States, 85381
Not Yet Recruiting
4
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85259
Not Yet Recruiting
5
National Heart Institute
Beverly Hills, California, United States, 90211
Actively Recruiting
6
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
7
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
8
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States, 91105
Actively Recruiting
9
University of California, San Francisco (UCSF) - Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
10
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
11
HCA Florida - JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
12
New Generation of Medical Research
Hialeah, Florida, United States, 33016
Actively Recruiting
13
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Not Yet Recruiting
14
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
15
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
16
New Generation of Medical Research - Naples
Naples, Florida, United States, 34116
Actively Recruiting
17
Flourish Research - St. Augustine
Saint Augustine, Florida, United States, 32086
Actively Recruiting
18
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
19
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
20
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Not Yet Recruiting
21
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
22
Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute
Elk Grove Village, Illinois, United States, 60007
Not Yet Recruiting
23
NorthShore University Health System
Glenview, Illinois, United States, 60026
Actively Recruiting
24
Riverside Medical Center - Illinois
Kankakee, Illinois, United States, 60901
Not Yet Recruiting
25
Midwest Cardiovascular Institute
Naperville, Illinois, United States, 60540
Actively Recruiting
26
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Not Yet Recruiting
27
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States, 46514
Not Yet Recruiting
28
University of Louisville Health
Louisville, Kentucky, United States, 40202
Actively Recruiting
29
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
30
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
31
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
32
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
33
Corewell Health
Royal Oak, Michigan, United States, 48073
Actively Recruiting
34
Henry Ford Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
35
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States, 55109
Not Yet Recruiting
36
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
37
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
38
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Not Yet Recruiting
39
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States, 08103
Not Yet Recruiting
40
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States, 85831
Not Yet Recruiting
41
Inspira Medical Centers
Mullica Hill, New Jersey, United States, 08062
Not Yet Recruiting
42
Inspira Medical Center of Vineland
Vineland, New Jersey, United States, 08302
Not Yet Recruiting
43
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
44
University of Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
45
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
46
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Actively Recruiting
47
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States, 27401
Actively Recruiting
48
Sanford Fargo
Fargo, North Dakota, United States, 58122
Actively Recruiting
49
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
50
Bethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio, United States, 45242
Not Yet Recruiting
51
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
52
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Not Yet Recruiting
53
Ascension St. John Hospital
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
54
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
55
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
56
OnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
57
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
58
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
59
St. David's Heart and Vascular dba Austin Heart - Main Office
Austin, Texas, United States, 78705
Actively Recruiting
60
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Not Yet Recruiting
61
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
62
University of Texas Medical Branch - Galveston
Houston, Texas, United States, 77555
Not Yet Recruiting
63
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
64
Methodist Hospital - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
65
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States, 77479
Not Yet Recruiting
66
University of Utah Hospital & Clinics
Salt Lake City, Utah, United States, 84112
Actively Recruiting
67
St. Boniface Hospital
Winnipeg, Mantioba, Canada, R2H 2A6
Not Yet Recruiting
68
Montreal Heart Institute - Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8
Not Yet Recruiting
69
Centre Hospitalier de l Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Not Yet Recruiting
70
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, Canada, GIV 4G5
Not Yet Recruiting
Research Team
K
Kardigan Clinical Trial Information Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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