Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy (NCT00998556) | Clinical Trial Compass
CompletedPhase 2
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
Germany64 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contraceptio…
What they're measuring
1
Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up