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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003710-34-DE

Enrollment

Registered

2009-01-07

Start date

2009-03-20

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripartum cardiomyopathy MedDRA version: 17.0 Level: HLT Classification code 10007635 Term: Cardiomyopathies System Organ Class: 100000004849

Interventions

Product Name: Bromocriptin Pharmaceutical Form: Tablet CAS Number: 22260511 Other descriptive name: BROMOCRIPTINE MESILATE

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Germany

Contacts

Public ContactAuthorized representative of the sp

Medizinische Hochschule Hannover

hilfiker.denise@mh-hannover.de0049511532-2531

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026