Peripartum Cardiomyopathy Clinical Trial
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
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.
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.
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