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

Grants and Contracts Details

Description

Scope of Work Required Baseline Visit: The subject’s medical record will be reviewed and clinical information recorded that includes demographics, past medical history, gravida/ para status, functional status (NYHA class), current lab work, current drug therapy, and previous cardiac evaluation. Participants will have an initial evaluation including assessment of vital signs (heart rate and blood pressure), height and weight, current requirement for intravenous inotropic therapy or temporary mechanical support, current requirement for clinical anticoagulation, and self-designated race. Subjects enrolled one month postpartum or more will take a brief assessment of mood (PHQ-8 ) to screen for postpartum depression (PPD), and an assessment of maternal infant bonding (Postpartum bonding questionnaire, PBQ). This assessment should only take 10 minutes for subjects to complete. Any PHQ-8 assessment which is positive for PPD (score of 10 or greater) will be discussed with the subject, and if they are not currently receiving treatment for PPD their primary physician/obstetrician will be notified to guide appropriate therapy. At the time of enrollment blood (approximately 25 ccs) will be obtained from study subjects including 10 cc for DNA banking and genotyping, 5 cc for RNA analysis and banking, and 10 cc for serum banking and mediator analysis. A baseline transthoracic echocardiogram will be obtained for the quantification of LVEF. Study drug (bromocriptine or placebo) will be initiated. One month after entry: In person face to face meeting. Current functional status (NYHA class) will be assessed, vital signs (heart rate and blood pressure) as well as current drug therapy. Medical compliance for study drug will be assess by pill count. Hospitalizations since the last visit will be reviewed. Subjects will complete the PHQ-8* and the PBQ assessment. Blood (15 ccs) will be obtained and shipped to the biomarker core for analysis of serum and whole blood RNA. Three months after entry: Face to face meeting. Current functional status (NYHA class) will be assessed, vital signs (heart rate and blood pressure) as well as current drug therapy. Medical compliance for study drug will be assess by pill count. Hospitalizations since the last visit will be reviewed. Subjects will complete the PHQ-8* and PBQ assessment. Blood (15 ccs) will be obtained and shipped to the biomarker core for analysis of serum and whole blood RNA. Six months after entry: Face to face meeting. Current functional status (NYHA class) will be assessed, vital signs (heart rate and blood pressure) as well as current drug therapy. Hospitalizations since the last visit will be reviewed. Subjects will complete the
StatusActive
Effective start/end date8/1/217/31/24

Funding

  • University of Pittsburgh: $2.00

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