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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00998556
Study type Interventional
Source Hannover Medical School
Contact
Status Completed
Phase Phase 2
Start date June 2010
Completion date August 2016

See also
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Completed NCT04049136 - NT-proBNP Levels and Obesity in Pregnancy
Recruiting NCT04234659 - PPCM Observational Study (Peripartum Cardiomyopathy)
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Recruiting NCT05878041 - Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.
Recruiting NCT04927715 - Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.