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 range
18 Years
Sex
FEMALE
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up