Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, controlled clinical trial to evaluate the efficacy and safety of bromocriptine for improvement of left ventricular function of women with Peripartum cardiomyopathy (PPCM). A Multi center trial in Germany.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: German Federal Ministry of Education and Research
• Treatments: Bromocriptine

Criteria

Inclusion Criteria:

• 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 1: 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.

• Age equal or greater 18

• Written informed consent of the patient

Exclusion Criteria:

• Preexisting cardiac disease (except PPCM which had complete resolution in a previous pregnancy)

• Any preexisting serious conditions

• Previous cardiac surgery or percutaneous coronary intervention

• History of alcohol and/or any other drug abuse

• Contraindication to the planned therapy (e. g. hypersensitivity to trial medication or one of its components)

• Concomitant therapy other than specified in the trial protocol such as products for treatment of fungal infections, psychotropic drugs, medication with the active substances diclofenace, verapamil or doxycycline.

• Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomized partner) during the conduct of the trial. Patients using hormonal methods of contraception must be informed about possible influences of the study drug on contraception, in addition heart failure drugs may interfere with contraception. Patients will be counselled about the safest method to be used for contraception.

• Expected low compliance (e.g. by travel distance to trial site)

• Concomitant participation in other clinical trials