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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

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.

AlabamaUniversity of Alabama Birmingham, Birmingham
ArizonaUniversity of Arizona Sarver Heart Center, Tucson
CaliforniaUniversity 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
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
ConnecticutHartford Hospital, Hartford
Yale University, New Haven
FloridaUniversity of Florida, Gainesville
Mayo Clinic, Florida, Jacksonville
University of South Florida, Tampa
GeorgiaEmory University, Atlanta
IllinoisNorthwestern University, Chicago
University of Illinois Health Heart Center, Chicago
IndianaAscension St. Vincent Heart Center, Indianapolis
Indiana University/Indiana University Health, Indianapolis
IowaUniversity of Iowa Hospitals and Clinic, Iowa City
KentuckyUniversity of Kentucky, Gill Heart & Vascular Institute, Lexington
LouisianaLouisiana State University, Shreveport
MarylandJohns Hopkins University, Baltimore
University of Maryland Medical Center, Baltimore, Baltimore
MassachusettsBrigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Health System, Detroit
MinnesotaMinneapolis Heart Institute Foundation, Minneapolis
University of Minnesota, Minneapolis
Mayo Clinic, Rochester, Rochester
MissouriKaren L Florio, MD, Columbia
Saint Luke's Hospital of Kansas City, Kansas City
Washington University School of Medicine, St Louis
New YorkColumbia 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 CarolinaAtrium Health Sanger Heart and Vascular Institute, Charlotte
OhioCleveland Clinic, Cleveland
University Hospitals, Cleveland Medical Center, Cleveland
OklahomaOklahoma university Health Science Center, Oklahoma City
PennsylvaniaPenn State Hershey Medical Center, Hershey
Temple Heart and Vascular Institute, Philadelphia
University of Pennsylvania, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
Rhode IslandRhode Island Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston
TennesseeStern Cardiovascular Foundation, Inc, Germantown
Vanderbilt, Nashville
TexasBaylor College of Medicine, Houston
UtahIntermountain Medical Center, Murray
VermontUniversity of Vermont Medical Center, Burlington
VirginiaUniversity of Virginia, Charlottesville
Inova Healthcare Services, Fairfax
Old Dominion University, Norfolk
Virginia Commonwealth University, Richmond
WashingtonUniversity of Washington Medical Center, Seattle
WisconsinUniversity 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.