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Could a simple pill delay heart valve surgery?

NCT ID NCT07001800

Disease control Sponsor: Kardigan, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study tests whether a daily medication called ataciguat can slow the progression of moderate aortic valve stenosis, a condition where the heart's aortic valve becomes narrowed. About 1,276 adults aged 50 and older will receive either ataciguat or a placebo for up to 3 years. Researchers will measure changes in valve calcium and valve area using CT scans and echocardiograms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ataciguat (a daily pill)
What this could lead to
If it works, this could provide a first medication to slow worsening of aortic valve narrowing, potentially delaying or avoiding the need for valve replacement surgery.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove effective. The study lasts up to 3 years, and side effects from long-term daily dosing are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \>300 to 1200 Agatston units (AU) for women and between \>300 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 in CPET sub-study in Part A and all participants in Part B: If 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 IV heart failure symptoms and/or requires continuous inotropes 6. Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid 7. Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery 8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate aortic valve stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    73 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute

    RECRUITING

    Elk Grove Village, Illinois, 60007, United States

  • Ascension St. John Hospital

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Atlantic Health System - Morristown Medical Center

    NOT_YET_RECRUITING

    Morristown, New Jersey, 85831, United States

  • Baylor Scott and White - The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Bethesda North Hospital, TriHealth, Inc

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cardiovascular Medicine

    NOT_YET_RECRUITING

    Moline, Illinois, 61265, United States

  • Centre Hospitalier de l Universite de Montreal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Deborah Heart and Lung Center

    NOT_YET_RECRUITING

    Browns Mills, New Jersey, 08015, United States

  • Duke University School of Medicine

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Flourish Research - St. Augustine

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • HCA Florida - JFK Hospital

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Heart Center Research LLC

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Henry Ford Hospital

    RECRUITING

    West Bloomfield, Michigan, 48322, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Houston Methodist Sugar Land Hospital

    NOT_YET_RECRUITING

    Sugar Land, Texas, 77479, United States

  • Inspira Medical Center of Vineland

    NOT_YET_RECRUITING

    Vineland, New Jersey, 08302, United States

  • Inspira Medical Centers

    NOT_YET_RECRUITING

    Mullica Hill, New Jersey, 08062, United States

  • Institut Universitaire de Cardiologie et de Pneumologie De Quebec

    RECRUITING

    Québec, Quebec, GIV 4G5, Canada

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • M Health Fairview St. John's Hospital

    NOT_YET_RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85259, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Healthcare System

    NOT_YET_RECRUITING

    Hollywood, Florida, 33021, United States

  • Methodist Dallas Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75203, United States

  • Methodist Hospital - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Methodist Medical Center of Illinois

    RECRUITING

    Peoria, Illinois, 61636, United States

  • Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Midwest Cardiovascular Research and Education Foundation

    RECRUITING

    Elkhart, Indiana, 46514, United States

  • Missouri Baptist Medical Center

    NOT_YET_RECRUITING

    St Louis, Missouri, 63131, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Montreal Heart Institute - Institut de Cardiologie de Montreal

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • National Heart Institute

    RECRUITING

    Beverly Hills, California, 90211, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • New Generation of Medical Research - Naples

    RECRUITING

    Naples, Florida, 34116, United States

  • NorthShore University Health System

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern University The Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OnSite Clinical Solutions, LLC - Rock Hill

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

  • Penn Medicine Lancaster General Hospital

    NOT_YET_RECRUITING

    Lancaster, Pennsylvania, 17602, United States

  • ProMedica Toledo Hospital

    NOT_YET_RECRUITING

    Toledo, Ohio, 43606, United States

  • Profound Research LLC at Southern California Heart Specialists

    RECRUITING

    Pasadena, California, 91105, United States

  • Providence St. Vincent Medical Center

    NOT_YET_RECRUITING

    Portland, Oregon, 97225, United States

  • Riverside Medical Center - Illinois

    NOT_YET_RECRUITING

    Kankakee, Illinois, 60901, United States

  • Sanford Fargo

    RECRUITING

    Fargo, North Dakota, 58122, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. Boniface Hospital

    NOT_YET_RECRUITING

    Winnipeg, Mantioba, R2H 2A6, Canada

  • St. David's Heart and Vascular dba Austin Heart - Main Office

    RECRUITING

    Austin, Texas, 78705, United States

  • The Heart Hospital at Deaconess Gateway

    NOT_YET_RECRUITING

    Newburgh, Indiana, 47630, United States

  • The Lindner Center for Research and Education at The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UCLA Ronald Reagan Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Alabama at Birmingham (UAB) - Medical Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Buffalo

    WITHDRAWN

    Buffalo, New York, 14203, United States

  • University of California, San Francisco (UCSF) - Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Louisville Health

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Texas Medical Branch - Galveston

    NOT_YET_RECRUITING

    Houston, Texas, 77555, United States

  • University of Utah Hospital & Clinics

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virtua Our Lady of Lourdes Hospital

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wellstar Kennestone Hospital

    NOT_YET_RECRUITING

    Marietta, Georgia, 30060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.