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Can a breastfeeding drug mend broken hearts after childbirth?

NCT ID NCT05180773

Disease control Sponsor: Dennis M. McNamara, MD, MS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This study tests whether bromocriptine, a drug that stops breastfeeding, can improve heart function in women newly diagnosed with peripartum cardiomyopathy (a type of heart failure after childbirth). 200 women will receive either bromocriptine or a placebo, plus standard heart failure care, for 8 weeks. Another 50 women who want to breastfeed will be observed without the drug. The main goal is to see if heart pumping ability improves at 6 months.

What this could mean

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

Active substance
Bromocriptine (a drug that blocks prolactin, often used to stop breastfeeding)
What this could lead to
If it works, this could offer a new treatment to help women with peripartum cardiomyopathy recover heart function and avoid heart failure, transplant, or a heart pump.
What could go wrong
This is a phase 4 trial, but the drug is already approved for other uses. It may not improve heart recovery, and it stops breastfeeding, which limits its use. Anticoagulation is needed to reduce clot risk.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

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

Started

Jul 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Female participants only

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.

Inclusion Criteria: 1. Presentation with a new diagnosis of peripartum cardiomyopathy 2. Post-delivery and within the first 5 months post-partum. 3. Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial 4. Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort 5. Age \> or = 18. Exclusion Criteria: 1. Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF \> 0.55 prior to or in early pregnancy) 2. Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF. 3. Postpartum women currently breastfeeding and planning to continue. 4. Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test) 5. Previous cardiac transplant 6. Current durable LVAD support 7. Currently requiring support with extracorporeal membrane oxygenation (ECMO) 8. Current history of alcohol or drug abuse 9. Chemotherapy or chest radiation within 5 years of enrollment 10. Evidence of ongoing bacterial septicemia 11. Medical, social or psychiatric condition which limit the ability to comply with follow-up.

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Conditions

The condition(s) this trial relates to.

peripartum cardiomyopathy

As listed by the trial registrant

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

Peripartum cardiomyopathy, postpartum

How to take part

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

  1. The places running it

    61 sites. 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

  • Albert Einstein College of Medicine/ Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Ascension St. Vincent Heart Center

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Atrium Health Sanger Heart and Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Indiana University/Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inova Healthcare Services

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Karen L Florio, MD

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Keck School of Medicine of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Lehigh Valley Health Network

    WITHDRAWN

    Allentown, Pennsylvania, 18105, United States

  • Louisiana State University

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic, Florida

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Mayo Clinic, Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10022, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oklahoma university Health Science Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Old Dominion University

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Penn State Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Saint Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • Stern Cardiovascular Foundation, Inc

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Stony Brook Medicine

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Temple Heart and Vascular Institute

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • UT Southern Medical Center

    WITHDRAWN

    Dallas, Texas, 75390-8830, United States

  • University Hospitals, Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of Arizona Sarver Heart Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California Irvine Health

    RECRUITING

    Orange, California, 92868, United States

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92037-7411, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Illinois Health Heart Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa Hospitals and Clinic

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky, Gill Heart & Vascular Institute

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland Medical Center, Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15237, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Texas Health San Antonio

    WITHDRAWN

    San Antonio, Texas, 78229, United States

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin Madison

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States