NCT05180773 Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
| NCT ID | NCT05180773 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dennis M. McNamara, MD, MS |
| Condition | Peripartum Cardiomyopathy, Postpartum |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-07-27 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2022-07-27 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Presentation with a new diagnosis of peripartum cardiomyopathy 2. Post-delivery and within the first 5 months post-partum. 3. Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial 4. Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort 5. Age \> or = 18. Exclusion Criteria: 1. 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) 2. Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF. 3. Postpartum women currently breastfeeding and planning to continue. 4. Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test) 5. Previous cardiac transplant 6. Current durable LVAD support 7. Currently requiring support with extracorporeal membrane oxygenation (ECMO) 8. Current history of alcohol or drug abuse 9. Chemotherapy or chest radiation within 5 years of enrollment 10. Evidence of ongoing bacterial septicemia 11. Medical, social or psychiatric condition which limit the ability to comply with follow-up.
Contact & Investigator
Dennis McNamara
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05180773 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Peripartum Cardiomyopathy, Postpartum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05180773 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05180773 currently recruiting?
Yes, NCT05180773 is actively recruiting participants. Contact the research team at mcnamaradm@upmc.edu for enrollment information.
Where is the NCT05180773 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, La Jolla, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05180773 clinical trial?
NCT05180773 is sponsored by Dennis M. McNamara, MD, MS. The principal investigator is Dennis McNamara at University of Pittsburgh. The trial plans to enroll 250 participants.