Peripartum Cardiomyopathy Clinical Trial
— PPCMOfficial 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
NCT number | NCT00998556 |
Other study ID # | PPCM |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | August 2016 |
Verified date | September 2020 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | August 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School (MHH) | Hannover | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up | Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography | 6 months | |
Secondary | Combined endpoint of hospitalization for heart failure, eligibility for cardiac transplantation, cardiac transplantation, and mortality during 6 months follow-up | 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 | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04144660 -
"Treatment Use of ECMO In Pregnancy or Peripartum Patient."
|
||
Withdrawn |
NCT04143997 -
Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery
|
||
Completed |
NCT03081949 -
Peripartum Cardiomyopathy in Nigeria Registry
|
Phase 4 | |
Recruiting |
NCT03364140 -
A Registry of Peripartum Cardiomyopathy in Turkey
|
N/A | |
Completed |
NCT04049136 -
NT-proBNP Levels and Obesity in Pregnancy
|
||
Recruiting |
NCT04234659 -
PPCM Observational Study (Peripartum Cardiomyopathy)
|
||
Withdrawn |
NCT02590601 -
Bromocriptine in the Treatment of Peripartum Cardiomyopathy
|
Phase 3 | |
Completed |
NCT03907267 -
Taurine in Peripartum Cardiomyopathy
|
Phase 2/Phase 3 | |
Recruiting |
NCT05878041 -
Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.
|
||
Recruiting |
NCT04927715 -
Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.
|