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New treatment option for Peripartum Cardiomyopathy, Postpartum
Official title Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
ClinicalTrials.gov ID: NCT05180773
What this study is testing
What is Bromocriptine?
Bromocriptine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripartum cardiomyopathy, postpartum.
Also referred to as Parlodel, Cycloset.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 3 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 assigned by chance control trial
- Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
- Age \> or = 18.
You likely can't join if
- Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum...
- 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
See the full eligibility 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 assigned by chance control trial
- Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
- Age \> or = 18.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Stanford, California, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.