Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
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.
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.
Our trial would establish a new specific therapeutic regimen for PPCM and we can expect that such a novel approach would be rapidly adopted in the clinical management of this disease. Since our trial design follows state-of the-art guidelines, we 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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Peripartum Cardiomyopathy
Intervention
Bromocriptine
Location
Hannover Medical School (MHH)
Hannover
Niedersachsen
Germany
30625
Status
Not yet recruiting
Source
Hannover Medical School
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00998556
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cardiomyopathies
A group of diseases in which the dominant feature is the involvement of the CARDIAC MUSCLE itself. Cardiomyopathies are classified according to their predominant pathophysiological features (DILATED CARDIOMYOPATHY; HYPERTROPHIC CARDIOMYOPATHY; RESTRICTIVE CARDIOMYOPATHY) or their etiological/pathological factors (CARDIOMYOPATHY, ALCOHOLIC; ENDOCARDIAL FIBROELASTOSIS).
Cardiomyopathy, Hypertrophic, Familial
An autosomal dominant inherited form of HYPERTROPHIC CARDIOMYOPATHY. It results from any of more than 50 mutations involving genes encoding contractile proteins such as VENTRICULAR MYOSINS; cardiac TROPONIN T; ALPHA-TROPOMYOSIN.
Peripartum Period
The period shortly before, during, and immediately after giving birth.
Bromocriptine
A semisynthetic ergotamine alkaloid that is a dopamine D2 agonist. It suppresses prolactin secretion.
Cardiomyopathy, Hypertrophic
A form of CARDIAC MUSCLE disease, characterized by left and/or right ventricular hypertrophy (HYPERTROPHY, LEFT VENTRICULAR; HYPERTROPHY, RIGHT VENTRICULAR), frequent asymmetrical involvement of the HEART SEPTUM, and normal or reduced left ventricular volume. Risk factors include HYPERTENSION; AORTIC STENOSIS; and gene MUTATION; (FAMILIAL HYPERTROPHIC CARDIOMYOPATHY).
Clinical Trials
Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other...
Registry and Survey of Women With Pregnancy Related Cardiomyopathy
The goal of this study is to better characterize peripartum cardiomyoapthy or pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both direct and web-bas...
Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets
The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine m...
Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine me...
The objective of the trial was to investigate the efficacy and safety of Pramipexole tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a doub...
PubMed Articles
Towards a unifying hypothesis for the pathogenesis of peripartum cardiomyopathy.
Peripartum cardiomyopathy is a pregnancy-associated myocardial disease characterized by the development of heart failure due to marked left ventricular systolic dysfunction. Although the disease is re...
Interventions for treating peripartum cardiomyopathy to improve outcomes for women and babies.
BACKGROUND: Peripartum cardiomyopathy (PPCM or PCMO) is a rare disease of unknown etiology, characterised by an acute onset of heart failure in women in the late stage of pregnancy or in the early mon...
Peripartum cardiomyopathy (PPCM) is a cause of pregnancy-associated heart failure. It typically develops during the last month of, and up to 6 months after, pregnancy in women without known cardiovasc...
