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New pill aims to strengthen hearts in genetic cardiomyopathy

NCT ID NCT07210723

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This study tests an experimental daily pill, danicamtiv, in 332 people with genetic or familial dilated cardiomyopathy (a weakened, enlarged heart). Participants take the drug or a placebo for about 6 months to see if it improves heart function and exercise ability. The goal is to control the disease, not cure it, as ongoing medication is expected.

Why investors are watching

Kardigan is testing danicamtiv, an experimental drug for genetic and familial dilated cardiomyopathy, a heart condition with no approved targeted treatment. For a micro-cap company with few products, this phase 2b/3 readout is the main driver of its value, as it will show whether the drug improves heart function and exercise capacity in 332 patients.

If it works: A positive result could establish danicamtiv as the first approved therapy for this specific form of heart disease, giving Kardigan a potential commercial product and validating its research pipeline.

If it fails: Trials often fail, and a negative or unclear result could leave Kardigan without a lead candidate, hurting its prospects and making it harder to fund further development.

AI-written from the trial record. Speculative, and not investment advice.

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 332 people

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

Started

Feb 2026

Expected to finish

Jan 2028

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

18 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. Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM 2. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month. 3. Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory. 4. Has a LVEF of ≤45%. 5. Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit. 6. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator. 7. Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05 Key Exclusion Criteria: 1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator. 2. Recent (\<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]), or hospitalization for heart failure/intravenous (IV) diuretic use. 3. Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. \> 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function. 4. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation). 5. History of malignancy of any type within 5 years prior to Screening 6. Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation \[sMDRD\]). 7. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation 8. History of heart transplantation or anticipated heart transplantation in the next 6 months. 9. Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement within 6 months 10. Clinically significant laboratory abnormalities at Screening

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Conditions

The condition(s) this trial relates to.

familial dilated cardiomyopathy

As listed by the trial registrant

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

Symptomatic genetic dilated cardiomyopathy

How to take part

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

  1. The places running it

    78 sites in 11 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

  • AP-HP Hopital Europeen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • AP-HP Hopital Pitie-Salpetriere

    RECRUITING

    Paris, 75013, France

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • AZORG - Campus Moorselbaan

    RECRUITING

    Aalst, 9300, Belgium

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Amsterdam UMC - Locatie AMC

    RECRUITING

    Amsterdam, 1105-AZ, Netherlands

  • Azienda Ospedale - Università Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari

    NOT_YET_RECRUITING

    Bari, 70124, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

    RECRUITING

    Trieste, 34100, Italy

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHRU de Tours - Hopital Trousseau

    NOT_YET_RECRUITING

    Chambray-lès-Tours, 37170, France

  • CHU Rennes - Hopital Pontchaillou

    NOT_YET_RECRUITING

    Rennes, 35033, France

  • CHU de Lille - Institut Coeur Poumon

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Cardiovascular Clinical Research Facility (CCRF)

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Cedars Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, 20138, Italy

  • Columbia University Medical Center/ New York Presbyterian Hospital

    NOT_YET_RECRUITING

    New York, New York, 10027, United States

  • Danderyds sjukhus

    NOT_YET_RECRUITING

    Stockholm, 182 88, Sweden

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27708, United States

  • Erasmus MC

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Policlinico San Matteo

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • Glenfield Hospital

    RECRUITING

    Leicester, LE3 9QP, United Kingdom

  • Hammersmith Hospital, Imperial College of London

    RECRUITING

    London, W12 0HS, United Kingdom

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120 El Palmar,, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Majadahonda, Madrid, 20222, Spain

  • Hospital Universitario Son Llatzer

    RECRUITING

    Palma de Mallorca, 7198, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Horta-Guinardó, Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29001, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Houston Methodist Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • IRCCS Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Jessa Ziekenhuis

    NOT_YET_RECRUITING

    Hasselt, 3500, Belgium

  • Johns Hopkins Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21218, United States

  • Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II

    RECRUITING

    Krakow, 31-202, Poland

  • Louisiana State University (LSU) Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Mayo Clinic - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie

    NOT_YET_RECRUITING

    Warsaw, 04-628, Poland

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Odense University Hospital - Odense

    RECRUITING

    Odense, 5000, Denmark

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ospedale Policlinico Casilino

    NOT_YET_RECRUITING

    Roma, 00169, Italy

  • Rigshospitalet

    RECRUITING

    Copenhagen, 1050, Denmark

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6NP, United Kingdom

  • Saint Luke's Mid America Heart Institute

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64111, United States

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    RECRUITING

    Lodz, 92-213, Poland

  • Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika

    RECRUITING

    Budapest, 1122, Hungary

  • Sodersjukhuset AB

    RECRUITING

    Stockholm, 11883, Sweden

  • St George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St. Bartholomew's Hospital

    RECRUITING

    London, EC1A, United Kingdom

  • Stanford University Medical Center

    NOT_YET_RECRUITING

    Stanford, California, 94305, United States

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    RECRUITING

    Szeged, 6724, Hungary

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

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94158, United States

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen (UZA)

    RECRUITING

    Edegem, 2650, Belgium

  • Universite Libre de Bruxelles (ULB) - Hopital Erasme

    RECRUITING

    Brussels, 1070, Belgium

  • University Hospitals Bristol NHS Foundation Trust

    RECRUITING

    Bristol, BS1 3NU, United Kingdom

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles (UCLA) - David Geffen School of Medicine

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Diego (UCSD) - Medical Center

    RECRUITING

    San Diego, California, 92037, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68106, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Uniwersyteckie Centrum Kliniczne, Gdansk

    NOT_YET_RECRUITING

    Gdansk, 80-952, Poland

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States