NCT05180773 · Dennis M. McNamara, MD, MS
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
(REBIRTH)
What this study is about
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomly assigned placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes.
View original scientific description
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.
Interventions
DRUG
Bromocriptine
Bromocriptine 2.5 mg one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects not on anticoagulation at the time of entry will also receive rivaroxaban 10 mg tablets once daily for 8 weeks while on bromocriptine.
DRUG
Placebo
Placebo one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects who are not on anticoagulation will not receive rivaroxaban but will receive a second placebo once daily for 8 weeks while on study drug.
DRUG
Guideline Directed Medical Therapy for Heart Failure (GDMT)
GDMT will potentially include angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor antagonists (ARB), angiotensin receptor blocker-neprilysin inhibitors (ARNI), beta adrenergic receptor antagonists (beta blockers) , Mineralocorticoid receptor antagonists (MRA), sodium-glucose cotransporter-2 inhibitors (SGLT2i),
DRUG
Rivaroxaban
Subjects not on anticoagulation clinically who are randomized to bromocriptine will receive rivaroxaban 10 mg tablets once tablet by mouth daily for 8 weeks while on bromocriptine.
DRUG
Second Placebo
Subjects not on anticoagulation clinically who are randomized to placebo (rather than bromocriptine) will receive a second placebo one tablet by mouth daily for 8 weeks.
Primary outcome measures
Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography
Time frame: 6 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 dur
Where
- Birmingham, Alabama
- Tucson, Arizona
- La Jolla, California
- Los Angeles, California
- Orange, California
- Stanford, California
- Aurora, Colorado
- Hartford, Connecticut
- New Haven, Connecticut
- Gainesville, Florida
- Jacksonville, Florida
- Tampa, Florida
And 42 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2025 · Source of record for eligibility and locations