RECRUITING

A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis

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Conditions

Moderate Aortic Valve StenosisAtaciguatsGC activatorsGC stimulatorAortic valve stenosisCalcific aortic valve stenosisCAVSModerate Calcific Aortic Valve StenosisAortic Stenosis (AS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 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

Quick Facts

Study Start:2025-06-27
Study Completion:2030-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07001800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult male or female at least 50 years of age
  2. 2. Has moderate CAVS as defined by:
  3. 1. An AVA of ≥1 cm2 to ≤1.50 cm2
  4. 2. An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men
  5. 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Core Laboratory
  6. 4. Can perform Cardiopulmonary Exercise Testing (CPET)
  1. 1. Has had a prior aortic valve replacement, repair, surgery, or intervention
  2. 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
  3. 3. Has known congenital aortic valve disease including bicuspid aortic valve
  4. 4. New York Heart Association (NYHA) Class III or Class IV
  5. 5. Has heart failure such as cardiomyopathy, congenital heart disease, myocarditis
  6. 6. Has coronary artery disease or anticipating coronary stenting surgery
  7. 7. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Contacts and Locations

Study Contact

Kardigan Clinical Trial Information Team
CONTACT
1-877-310-5135
clinicaltrials@kardigan.bio

Study Locations (Sites)

University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, 35233
United States
Heart Center Research LLC
Huntsville, Alabama, 35801
United States
National Heart Institute
Beverly Hills, California, 90211
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
New Generation of Medical Research - Naples
Naples, Florida, 34116
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
University of South Florida
Tampa, Florida, 33606
United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, 60611
United States
NorthShore University Health System
Glenview, Illinois, 60026
United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
United States
St. Vincent Medical Group, Inc.
Carmel, Indiana, 46290
United States
University of Iowa Health Care
Iowa City, Iowa, 52242
United States
Cardiovascular Consultants of Kansas, P.A.
Wichita, Kansas, 67226
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
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Washington University
St. Louis, Missouri, 63110
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
University of Buffalo
Buffalo, New York, 14203
United States
Northwell Health
Manhasset, New York, 11030
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
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ascension St. John Jane Phillips Hospital
Bartlesville, Oklahoma, 74006
United States
Ascension St. John Hospital
Tulsa, Oklahoma, 74104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
York Hospital Heart and Vascular Research Office
York, Pennsylvania, 17403
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States
Ascension Saint Thomas Heart Midtown
Nashville, Tennessee, 37205
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
Houston Methodist Hospital
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
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
University of Utah Hospital & Clinics
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Kardigan, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27
Study Completion Date2030-09-30

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

  • Ataciguat
  • sGC activator
  • sGC stimulator
  • Aortic valve stenosis
  • Moderate aortic valve stenosis
  • Calcific aortic valve stenosis
  • CAVS
  • Moderate Calcific Aortic Valve Stenosis
  • Aortic Stenosis (AS)

Additional Relevant MeSH Terms

  • Moderate Aortic Valve Stenosis