(1/2) randomized evaluation of bromocriptine in myocardial recovery therapy for peripartum cardiomyopathy (rebirth)

Active Cooperative Agreement Awarded Last action

Award ID
UH3HL153847
Recipient
Awarding agency
Obligated
$4,940,533

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date 87% complete
Originally
Place of performance
Pittsburgh, PA 15213, USA

Award details come from USAspending.gov.

Description

Abstract
Peripartum cardiomyopathy (ppcm) is a complication of pregnancy occurring in 1 in 2000 live births, which remains a major cause of maternal morbidity and mortality. Inhibition of prolactin with the dopaminergic agonist bromocriptine appears to improve outcomes in small clinical studies of ppcm in africa and europe; however, no randomized trial has been performed in a diverse multi-racial north american cohort comparing bromocriptine against standard heart failure therapy. 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.

Transactions

Action Obligated Date
Amendment $0
Amendment $677,240
Amendment $727,524
Amendment $122,207
Amendment $744,936
Amendment $0
Amendment $0
Amendment $889,542
Amendment $889,542
Original award $889,542

Subawards

Subrecipient Amount Awarded
University Of South Florida (1/2) Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH) $19,734
Cleveland Clinic Lerner College Of Medicine Of Case Western Reserve University The subaward site will contribute by recruiting patients with PPCM to the randomized trial of 200 women to eight weeks of bromocriptine or placebo. $22,540
University Of Florida (1/2) Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH) $56,358
The Pennsylvania State University $16,073
Hartford Hospital Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy $16,147
Yale Univ (1/2) Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH) $0
Saint Luke's Hospital Of Kansas City $0
The Pennsylvania State University $57,800
The Pennsylvania State University $56,469
Pennsylvania State University $141,986
Virginia Commonwealth University $10,247
Show all 11

Quick answers

Who received award UH3HL153847?

UH3HL153847 was awarded to University Of Pittsburgh - Of The Commonwealth System Of Higher Education by National Heart Lung and Blood Institute (National Institutes of Health) on August 1, 2021.

How much is award UH3HL153847 worth?

$4,940,533 has been obligated on UH3HL153847.

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