Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Recruiting
Phase 4Interventional Study
Peripartum Cardiomyopathy, Postpartum
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Dennis M. McNamara, MD, MS · Other
Who this trial is looking for
This trial is looking for women recently diagnosed with peripartum cardiomyopathy, which is heart failure that happens around the time of childbirth. Participants will receive either bromocriptine or a placebo to see how it affects their heart recovery and overall health.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with peripartum cardiomyopathy.
I am within 5 months after giving birth.
My heart function (LVEF) is 40% or lower.
I am at least 18 years old.
You may not be able to join if
I have been diagnosed with other types of heart disease before.
I have high blood pressure that is not controlled.
I am currently breastfeeding and plan to continue.
I have heart artery disease.
I have had a heart transplant.
I am on a heart pump device.
I am on life support with ECMO.
I have a history of drug or alcohol abuse.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 brea…
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.
Trial Locations
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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…
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.
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