Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)
Dennis M. McNamara, MD, MS
250 participants
Jul 27, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Presentation with a new diagnosis of peripartum cardiomyopathy
- Post-delivery and within the first 5 months post-partum.
- Clinical assessment of an LVEF < or =0.40 within 4 weeks of consent for randomized control trial
- Clinical assessment of an LVEF < or =0.40 within 8 weeks of consent for breastfeeding cohort
- Age > or = 18.
Exclusion Criteria11
- 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)
- Refractory hypertension (Systolic >160 or Diastolic > 95) either at the time of enrollment or at the time of the qualifying LVEF.
- Postpartum women currently breastfeeding and planning to continue.
- Evidence of coronary artery disease (>50% stenosis of major epicardial vessel or positive non-invasive stress test)
- Previous cardiac transplant
- Current durable LVAD support
- Currently requiring support with extracorporeal membrane oxygenation (ECMO)
- Current history of alcohol or drug abuse
- Chemotherapy or chest radiation within 5 years of enrollment
- Evidence of ongoing bacterial septicemia
- Medical, social or psychiatric condition which limit the ability to comply with follow-up.
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Interventions
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.
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.
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),
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.
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.
Locations(64)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05180773