Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripartum Cardiomyopathy
Intervention: Bromocriptine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hannover Medical School Official(s) and/or principal investigator(s):
Johann Bauersachs, Prof. Dr., Principal Investigator, Affiliation: Hannover Medical School, Hannover, Germany
Denise Hilfiker-Kleiner, Prof. Dr., Study Chair, Affiliation: Hannover Medical School, Hannover, Germany
Overall contact:
Johann Bauersachs, Prof. Dr. med., Phone: (0)511-532-3840, Ext: 0049, Email: bauersachs.johann@mh-hannover.de
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 Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography
Secondary outcome: 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
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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 contraception. Patients will be counselled
about the safest method to be used for contraception.
- Expected low compliance (e. g. by travel distance to trial site)
- Concomitant participation in other clinical trials
Locations and Contacts
Johann Bauersachs, Prof. Dr. med., Phone: (0)511-532-3840, Ext: 0049, Email: bauersachs.johann@mh-hannover.de
Hannover Medical School (MHH), Hannover, Niedersachsen 30625, Germany; Recruiting
Johann Bauersachs, Prof. Dr. med., Phone: (0)511-532-3840, Ext: 0049, Email: bauersachs.johann@mh-hannover.de
Denise Hilfiker-Kleiner, Prof. Dr., Phone: (0)511-532-2531, Ext: 0049, Email: hilfiker.denise@mh-hannover.de
Bauersachs Johann, Prof. Dr. med., Principal Investigator
Additional Information
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Starting date: June 2010
Last updated: September 12, 2012
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