EUCTR2007-003710-34-DEActive, not recruitingPhase 1
EFFECT OF BROMOCRIPTINE ON LEFT VENTRICULAR FUNCTION IN WOMEN WITH PERIPARTUM CARDIOMYOPATHY - PPCM Studie
Medizinische Hochschule Hannover0 sites63 target enrollmentStarted: January 7, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 63
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Patients must meet ALL of the following 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: 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.
- •Written informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •Patients will be excluded for ANY ONE of the following reasons:
- •1.Preexisting cardiac disease (except PPCM which had complete resolution) in a previous pregnancy)
- •2.Any preexisting serious conditions
- •3.Previous cardiac surgery or percutaneous coronary intervention
- •4.History of alcohol and/or any other drug abuse
- •5.Contraindication to the planned therapy (e. g. hypersensitivity to trial medication or one of its components)
- •6.Concomitant therapy other than specified in the trial protocol
- •7.Expected low compliance (e.g. by travel distance to trial site)
- •8.Concomitant participation in other clinical trials.
Investigators
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