Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (NCT05180773) | Clinical Trial Compass
RecruitingPhase 4
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
United States250 participantsStarted 2022-07-27
Plain-language summary
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.
Who can participate
Age range18 Years
SexFEMALE
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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)
✕
What they're measuring
1
Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography