Actively Recruiting

Phase 2
Phase 3
Age: 50Years +
All Genders
NCT07001800

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

Led by Kardigan, Inc. · Updated on 2026-05-06

1276

Participants Needed

70

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male or female at least 50 years of age
  • Moderate calcific aortic valve stenosis defined by an aortic valve area of 1.0 to 1.5 cm2
  • Aortic valve calcium score between >300 to 1200 Agatston units for women and >300 to 2000 for men
  • Left ventricular ejection fraction of 45% or higher at screening
  • Stable beta blocker dose for at least 90 days prior to screening if applicable
Not Eligible

You will not qualify if you...

  • Medical or physical conditions preventing completion of exercise testing (e.g., pulmonary disease, joint or back conditions)
  • Planned or anticipated aortic valve replacement, repair, surgery, or intervention within 6 months
  • Moderate to severe mitral or aortic valve disease (stenosis or regurgitation, Grade 2 or higher)
  • Known or suspected congenital aortic valve disease including bicuspid valve
  • NYHA Class IV heart failure or need for continuous inotropes
  • History of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
  • Untreated obstructive coronary artery disease or planned coronary stenting
  • Abnormal ECG or persistent/permanent atrial fibrillation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

K

Kardigan Clinical Trial Information Team

CONTACT

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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