EFFECT OF BROMOCRIPTINE ON LEFT VENTRICULAR FUNCTION IN WOMEN WITH PERIPARTUM CARDIOMYOPATHY

Phase 1

• Conditions: Peripartum cardiomyopathy; MedDRA version: 17.0Level: HLTClassification code 10007635Term: CardiomyopathiesSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-003710-34-DE
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-07
• Study Completion: 2016-03-04
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 63

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.
•Age < 18
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of bromocriptine for improvement of the left ventricular function in women with peripartum cardiomyopathy (PPCM). ;Secondary Objective: Decreasing hospitalization for heart failure symptoms, cardiac transplantations, and mortality during 6 months follow-up. ;Primary end point(s): Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography;Timepoint(s) of evaluation of this end point: baseline and 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Decreasing hospitalization for heart failure symptoms<br>2.Decreasing cardiac transplantations<br>3.Decreasing mortality during 6 months follow-up<br>4.Describing the combined endpoint of 6-month mortality, cardiac transplantation and hospitalization for heart failure<br>;Timepoint(s) of evaluation of this end point: During 6 months