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Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
RecruitingPhase 4
Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)
Who can join
Ages 18 and older · Women
Full eligibility criteria
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.
About the study
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.
What is being tested
- Bromocriptine (drug)
- Placebo (drug)
- Guideline Directed Medical Therapy for Heart Failure (GDMT) (drug)
- Rivaroxaban (drug)
- Second Placebo (drug)
Sponsor: Dennis M. McNamara, MD, MS · Participants: 250 · Started: Jul 27, 2022
Contact the study team
Official record on ClinicalTrials.gov — NCT05180773
Locations in the U.S.
| Alabama | University of Alabama Birmingham, Birmingham |
| Arizona | University of Arizona Sarver Heart Center, Tucson |
| California | University of California San Diego, La Jolla Cedars-Sinai Medical Center, Los Angeles Keck School of Medicine of USC, Los Angeles University of California Irvine Health, Orange Stanford University, Stanford |
| Colorado | University of Colorado Anschutz Medical Campus, Aurora |
| Connecticut | Hartford Hospital, Hartford Yale University, New Haven |
| Florida | University of Florida, Gainesville Mayo Clinic, Florida, Jacksonville University of South Florida, Tampa |
| Georgia | Emory University, Atlanta |
| Illinois | Northwestern University, Chicago University of Illinois Health Heart Center, Chicago |
| Indiana | Ascension St. Vincent Heart Center, Indianapolis Indiana University/Indiana University Health, Indianapolis |
| Iowa | University of Iowa Hospitals and Clinic, Iowa City |
| Kentucky | University of Kentucky, Gill Heart & Vascular Institute, Lexington |
| Louisiana | Louisiana State University, Shreveport |
| Maryland | Johns Hopkins University, Baltimore University of Maryland Medical Center, Baltimore, Baltimore |
| Massachusetts | Brigham and Women's Hospital, Boston Massachusetts General Hospital, Boston |
| Michigan | University of Michigan, Ann Arbor Henry Ford Health System, Detroit |
| Minnesota | Minneapolis Heart Institute Foundation, Minneapolis University of Minnesota, Minneapolis Mayo Clinic, Rochester, Rochester |
| Missouri | Karen L Florio, MD, Columbia Saint Luke's Hospital of Kansas City, Kansas City Washington University School of Medicine, St Louis |
| New York | Columbia University Irving Medical Center, New York Mount Sinai Hospital, New York NYU Langone Health, New York University of Rochester, Rochester Stony Brook Medicine, Stony Brook Albert Einstein College of Medicine/ Montefiore Medical Center, The Bronx |
| North Carolina | Atrium Health Sanger Heart and Vascular Institute, Charlotte |
| Ohio | Cleveland Clinic, Cleveland University Hospitals, Cleveland Medical Center, Cleveland |
| Oklahoma | Oklahoma university Health Science Center, Oklahoma City |
| Pennsylvania | Penn State Hershey Medical Center, Hershey Temple Heart and Vascular Institute, Philadelphia University of Pennsylvania, Philadelphia University of Pittsburgh Medical Center, Pittsburgh |
| Rhode Island | Rhode Island Hospital, Providence |
| South Carolina | Medical University of South Carolina, Charleston |
| Tennessee | Stern Cardiovascular Foundation, Inc, Germantown Vanderbilt, Nashville |
| Texas | Baylor College of Medicine, Houston |
| Utah | Intermountain Medical Center, Murray |
| Vermont | University of Vermont Medical Center, Burlington |
| Virginia | University of Virginia, Charlottesville Inova Healthcare Services, Fairfax Old Dominion University, Norfolk Virginia Commonwealth University, Richmond |
| Washington | University of Washington Medical Center, Seattle |
| Wisconsin | University of Wisconsin Madison, Madison Medical College of Wisconsin, Milwaukee |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.