Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH)

Project: Research project

Project Details

Description

The purpose of the Randomized Evaluation of Bromocriptine Therapy for Peripartum Cardiomyopathy (REBIRTH) trial is to evaluate whether the addition of bromocriptine to standard heart failure therapy improves outcomes in women with PPCM. This multicenter trial, Randomized Evaluation of Bromocriptine In Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH), will evaluate whether the addition of bromocriptine to standard therapy improves outcomes for women with PPCM. This trial will randomize 200 women with PPCM to eight weeks of bromocriptine or placebo. Left ventricular ejection fraction will be determined by echocardiography at study entry, and reassessed at 6 and 12 months after randomization to determine whether the addition of bromocriptine improves left ventricular function and overall clinical outcomes. For women presenting with PPCM, echocardiographic assessment of left ventricular dysfunction and remodeling helps predict the probability of recovery. This proposal will evaluate whether global longitudinal strain or left ventricular diastolic volume will predict the therapeutic response to bromocriptine. The therapeutic impact of bromocriptine is theoretically a result of the reduction of prolactin and prolactin fragments collectively known as vasoinhibins. This investigation will investigate whether higher levels of these biomarkers predict greater benefit from bromocriptine. Breastfeeding raises prolactin levels, and the impact of breastfeeding on recovery from PPCM remains controversial. Given that bromocriptine causes cessation of lactation, women with PPCM who want to continue breastfeeding are excluded from the randomized trial. This proposal will follow 50 such women and investigate the levels of these biomarkers and whether the recovery of left ventricular function differs in breastfeeding women. REBIRTH will clarify the role of bromocriptine for the treatment of this disorder. This proposal will also evaluate the impact of breastfeeding, and will have a significant impact on the overall management of women with PPCM.
StatusActive
Effective start/end date9/15/227/31/26

Funding

  • University of Pittsburgh (AWD00004314 (139454-47A) Amendment 2 // 5UH3HL153847-03)
  • National Heart, Lung, and Blood Institute (AWD00004314 (139454-47A) Amendment 2 // 5UH3HL153847-03)

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