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

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.

Grant Number: 5U24HL153846-05
NIH Institute/Center: NIH
Principal Investigator: Kaleab Abebe