(2/2) Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)

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ABSTRACT The United States has one of the highest rates of maternal mortality in the developed world, and is one of few countries where this rate is increasing. Peripartum cardiomyopathy (PPCM) remains a major cause of maternal morbidity and mortality. While improvement in myocardial function occurs within the first 12 months postpartum in more than half of women with PPCM, those who do not recover are left with chronic heart failure and 5-10% of women die or require cardiac transplantation during the first-year post-partum. Inhibition of prolactin with the dopamine agonist bromocriptine appears to improve outcomes in three previous clinical studies of PPCM. Recent recommendations from a European working group suggest the addition of bromocriptine to standard heart failure therapy; however, no randomized trial comparing standard therapy to standard therapy plus bromocriptine has been performed in a multi-racial North American cohort. The purpose of this investigation is to evaluate whether the addition of bromocriptine to standard heart failure therapy improves outcomes in women with PPCM in a randomized controlled trial. The University of Pittsburgh Center for Clinical Trials & Data Coordination (CCDC) proposes to serve as the Data Coordinating Center (DCC) for the proposed Randomized Evaluation of Bromocriptine Therapy for Peripartum Cardiomyopathy (REBIRTH) study. We currently serve as the DCC for numerous single- and multi-center clinical trials in which we support many complex aspects of the study including project management, protocol development, data management, regulatory support, statistical analyses, and data dissemination. The CCDC will collaborate with study investigators to design, conduct, coordinate, and analyze the proposed REBIRTH clinical trial. Specifically, we propose to 1) provide program coordination and administrative support throughout all phases (UG3 and UH3) of REBIRTH; 2) coordinate protocol development during the UG3 phase, provide regulatory management throughout the study, and establish collaborations with key core facilities; 3) adapt and maintain an existing web-based data management and tracking system to enhance the integrity and rigor of REBIRTH; and 4) provide comprehensive expertise for the design and statistical analysis of REBIRTH.