Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Overview

About this study

The purpose of this study is to evaluate the impact of bromocriptine on myocardial recovery and clinical outcomes in women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum.  Given that bromocriptine prevents breastfeeding, women with peripartum cardiomyopathy will be excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/27/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathleen Young, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

Jacksonville, Fla.

Mayo Clinic principal investigator

Demilade Adedinsewo, M.B., Ch.B.

Open for enrollment

Contact information:

Jessica Murphey

(904) 953-4512

Murphey.Jessica@mayo.edu

More information

Publications

Publications are currently not available