Bromocriptine treatment for women with peripartum cardiomyopathy
Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)
This study is testing if bromocriptine can help women with peripartum cardiomyopathy recover their heart function better than standard treatment alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 64 sites (Birmingham, Alabama and 63 other locations) |
| Trial ID | NCT05180773 on ClinicalTrials.gov |
What this trial studies
This study enrolls 200 women diagnosed with peripartum cardiomyopathy within 5 months postpartum to evaluate the effects of bromocriptine therapy on heart recovery. Participants will be randomly assigned to receive either bromocriptine alongside standard heart failure treatment or a placebo with standard treatment. The study will assess heart function through echocardiograms at baseline, 6 months, and 12 months, while also monitoring long-term outcomes over three years. An additional cohort of breastfeeding women will be observed to gather data without bromocriptine treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, newly diagnosed with peripartum cardiomyopathy within 5 months postpartum and with a left ventricular ejection fraction (LVEF) of 40% or less.
Not a fit: Patients with a history of other types of cardiomyopathy, significant coronary artery disease, or those currently breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart recovery and clinical outcomes for women suffering from peripartum cardiomyopathy.
How similar studies have performed: While the use of bromocriptine in this context is novel, previous studies have shown promise in treating other conditions with similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 63 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Arizona Sarver Heart Center — Tucson, Arizona, United States (Recruiting)
- University of California San Diego — La Jolla, California, United States (Recruiting)
- Keck School of Medicine of USC — Los Angeles, California, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California Irvine Health — Orange, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Mayo Clinic, Florida — Jacksonville, Florida, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Illinois Health Heart Center — Chicago, Illinois, United States (Recruiting)
- Indiana University/Indiana University Health — Indianapolis, Indiana, United States (Recruiting)
- Ascension St. Vincent Heart Center — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa Hospitals and Clinic — Iowa City, Iowa, United States (Recruiting)
- University of Kentucky, Gill Heart & Vascular Institute — Lexington, Kentucky, United States (Recruiting)
- Louisiana State University — Shreveport, Louisiana, United States (Recruiting)
- University of Maryland Medical Center, Baltimore — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic, Rochester — Rochester, Minnesota, United States (Recruiting)
- Karen L Florio, MD — Columbia, Missouri, United States (Recruiting)
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- Stony Brook Medicine — Stony Brook, New York, United States (Recruiting)
- Albert Einstein College of Medicine/ Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Atrium Health Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States (Recruiting)
- University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Oklahoma university Health Science Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States (Withdrawn)
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Temple Heart and Vascular Institute — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
+14 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Dennis McNamara — University of Pittsburgh
- Study coordinator: Dennis McNamara, MD
- Email: mcnamaradm@upmc.edu
- Phone: 412-802-3131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.