PARTICIPANTS

Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy (REBIRTH) for Peripartum Cardiomyopathy

What is Peripartum Cardiomyopathy (PPCM)?

PPCM is a heart muscle weakness that occurs during or following pregnancy. “Cardiomyopathy” means sickness of your heart muscle. In this condition, your heart has become enlarged and weak and does not pump as well as it normally should. This condition often results in feeling short of breath or tired when you are trying to move or exercise. Research suggests that both family traits from your parents (known as your genes) and inflammation of the heart muscle can cause your heart to become weak. “Inflammation” can include redness, swelling, pain, tenderness, warmth, and a change in how any area of your body, such as your heart, is working. These factors may also be why you have PPCM. The overall cause of PPCM remains unknown.

What is the purpose of the study?

The purpose of REBIRTH is to test the use of a drug called bromocriptine for women who have PPCM. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill. Bromocriptine is approved by the United States Food and Drug Administration (FDA) to treat irregular periods and other symptoms that result from having high blood levels of a substance called prolactin. It is not approved for use in usual care to treat PPCM.

Who is being asked to be in the study?

Women with a recent diagnosis of PPCM who are 18 years of age or older, within 5 months after delivery and not breastfeeding. Women who breastfeed may be eligible to be in group that does not take study drug.

What would I need to do to be in the study?

In-person entry study visit lasts approximately 2-2.5 hours
In person follow up visits at Month 1, Month 3, Month 6, Month 12 last approximately 1-1.5 hours
Follow up visits at Month 24 and Month 36 can be done in-person or remotely
Procedures during these visits may include:
- clinical assessment
- medical history
- research blood draw for biomarkers done at 4 visits
- echocardiogram
- questionnaires
- study drug counts
Take study drug for 8 weeks
Duration of participation: approximately 3 years

Have any questions? Let us know!