Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy (PPCM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Bromocriptine on LV Function in Women With Peripartum Cardiomyopathy A Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Bromocriptine for Improvement of Left Ventricular Function of Women With PPCM|
- Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Combined endpoint of hospitalization for heart failure, eligibility for cardiac transplantation, cardiac transplantation, and mortality during 6 months follow-up; individual components of the combined endpoint; adverse events [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks, thereafter the patients continue to be observed in the follow-up part of the study up to month 6. The study medication is taken on top of standard therapy for heart failure. Part of this therapy are ACE inhibitors. ACE inhibitors are potentially harmful for the baby when getting into the breast milk, as bromocriptine stops milk production, no additional drug is needed.
Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks. The study medication is taken on top of standard therapy for heart failure.
Other Name: n.a.
No Intervention: Control Group
The control group will receive standard therapy for heart failure. Part of this therapy are ACE inhibitors. Since ACE inhibitors are potentially harmful for the baby when getting into the breast milk, it is necessary to stop lactation in the control group as well.To stop lactation, application of bromocriptine (2.5mg/day) for up to one week.
Peripartum cardiomyopathy (PPCM) is a serious life threatening heart disease of unknown etiology in previously healthy women. Only a minority of patients recovers completely while the majority of PPCM patients develop persistent ventricular dysfunction and may experience severe heart failure leading to cardiac transplantation. Thus, these young patients are very sick at a time when the newborn would need a healthy mother. Many of PPCM patients need lifelong treatment causing a large financial and social burden. Indeed, a better understanding of the disease and more efficient therapeutic options are urgently needed. To date, no specific therapy is available so that patients are treated by medical pharmacotherapy for heart failure.
Diagnosis of PPCM is usually made at advanced stages of the disease in severely symptomatic women but prognosis of affected women is poor with reported mortality rates of 15% and recovery in only 23% to 54% of PPCM patients despite optimal medical treatment. Therefore strategies are urgently needed to identify patients at risk and novel therapeutic approaches are required to improve poor prognosis of affected women.
The trial would establish a new specific therapeutic regimen for PPCM and the investigators can expect that such a novel approach would be rapidly adopted in the clinical management of this disease. Since the trial design follows state-of the-art guidelines, the investigators assume that bromocriptine would shortly be adopted into clinical guidelines of the German Cardiac Society, European Cardiac Society, and the American Heart Association.
|Contact: Johann Bauersachs, Prof. Dr. med.||(0)511-532-3840 ext email@example.com|
|Contact: Denise Hilfiker-Kleiner, Prof. Dr.||(0)511-532-2531 ext firstname.lastname@example.org|
|Hannover Medical School (MHH)||Recruiting|
|Hannover, Niedersachsen, Germany, 30625|
|Contact: Johann Bauersachs, Prof. Dr. med. (0)511-532-3840 ext 0049 email@example.com|
|Contact: Denise Hilfiker-Kleiner, Prof. Dr. (0)511-532-2531 ext 0049 firstname.lastname@example.org|
|Principal Investigator: Bauersachs Johann, Prof. Dr. med.|
|Principal Investigator:||Johann Bauersachs, Prof. Dr.||Hannover Medical School, Hannover, Germany|
|Study Chair:||Denise Hilfiker-Kleiner, Prof. Dr.||Hannover Medical School, Hannover, Germany|