Efficacy of bromocriptine on left ventricular function in women with peripartum cardiomyopathy (PPCM)
- Conditions
- PPCM: Peripartum CardiomyopathyO99.4Diseases of the circulatory system complicating pregnancy, childbirth and the puerperium
- Registration Number
- DRKS00000407
- Lead Sponsor
- Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 63
1. Female subjects in the first 5 months postpartum with new onset of left ventricular (LV) dysfunction (LV ejection fraction <35% as assessed by echocardiography) using the internationally accepted criteria for PPCM: absence of an identifiable cause of heart failure, absence of recognizable heart disease prior to the last month of pregnancy and LV systolic dysfunction demonstrated by classical echocardiographic criteria.
2. Written informed consent of the patient
1. Preexisting cardiac disease (except PPCM which had complete resolution) in a previous pregnancy)
2. Any preexisting serious conditions
3. Previous cardiac surgery or percutaneous coronary intervention
4. History of alcohol and/or any other drug abuse
5. Contraindication to trial medication or one of its components
6. Concomitant therapy other than specified in the trial protocol
8. Expected low compliance
9. Concomitant participation in other clinical trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in LVEF from baseline to 6 months follow-up as assessed by cardiac magnetic resonance imaging (MRI).
- Secondary Outcome Measures
Name Time Method Combined endpoints of hospitalization for heart-failure, cardiac transplantation, and mortality during 6 months follow-up; individual components of the combined endpoint.