Bromocriptine for Myocardial Recovery in Peripartum Cardiomyopathy: Design and Rationale of the REBIRTH Trial.

BACKGROUND

There is evidence suggesting that bromocriptine potentially improves outcomes among women with peripartum cardiomyopathy (PPCM); however, there is currently no randomized controlled trial comparing bromocriptine vs placebo on top of guideline-directed medical therapy (GDMT) in a diverse, multiethnic cohort in North America.

OBJECTIVES

The REBIRTH trial will enroll 200 women with PPCM to evaluate whether the addition of oral bromocriptine to GDMT is superior to placebo for improving myocardial function and event-free survival. In addition to the randomized trial, REBIRTH will enroll 50 women with PPCM excluded from randomization because of breastfeeding into an observational cohort.

METHODS

The principal inclusion criteria are ≥18 years of age, within 5-months postpartum, and left ventricular ejection fraction (LVEF) ≤40%. The primary endpoint is LVEF at 6 months postrandomization. Secondary endpoints include LVEF at 12 months, survival free from major events (ie, death, heart transplantation, or implantation of a durable left ventricular assist device), and survival free from heart failure hospitalization for up to 3 years.

RESULTS

The study is currently enrolling women in both the randomized trial and observational breastfeeding cohort. Primary results are expected to be reported in 2027.

CONCLUSIONS

REBIRTH will determine whether the addition of bromocriptine to GDMT for heart failure with reduced ejection fraction improves postpartum myocardial recovery and clinical outcomes in a diverse cohort of women with PPCM. (Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for PPCM [REBIRTH]; NCT05180773).