StudyFinder
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
RECRUITING
18 years and over
Inclusion Criteria:
• Presentation with a new diagnosis of peripartum cardiomyopathy
• Post-delivery and within the first 5 months post-partum.
• Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
• Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
• Age \> or = 18.
Exclusion Criteria:
• Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF \> 0.55 prior to or in early pregnancy)
• Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF.
• Postpartum women currently breastfeeding and planning to continue.
• Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
• Previous cardiac transplant
• Current durable LVAD support
• Currently requiring support with extracorporeal membrane oxygenation (ECMO)
• Current history of alcohol or drug abuse
• Chemotherapy or chest radiation within 5 years of enrollment
• Evidence of ongoing bacterial septicemia
• Medical, social or psychiatric condition which limit the ability to comply with follow-up.
DRUG: Bromocriptine, DRUG: Placebo, DRUG: Guideline Directed Medical Therapy for Heart Failure (GDMT), DRUG: Rivaroxaban, DRUG: Second Placebo
Peripartum Cardiomyopathy, Postpartum
Dennis McNamara, MD - mcnamaradm@upmc.edu
PHASE4
NCT05180773