Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy (PPCM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Denise Hilfiker-Kleiner, PhD, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00998556
First received: October 19, 2009
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Peripartum Cardiomyopathy
Drug: Bromocriptine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromocriptine
Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks, thereafter the patients continue to be observed in the follow-up part of the study up to month 6. The study medication is taken on top of standard therapy for heart failure. Part of this therapy are ACE inhibitors. ACE inhibitors are potentially harmful for the baby when getting into the breast milk, as bromocriptine stops milk production, no additional drug is needed.
Drug: Bromocriptine
Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks. The study medication is taken on top of standard therapy for heart failure.
Other Name: n.a.
No Intervention: Control Group
The control group will receive standard therapy for heart failure. Part of this therapy are ACE inhibitors. Since ACE inhibitors are potentially harmful for the baby when getting into the breast milk, it is necessary to stop lactation in the control group as well.To stop lactation, application of bromocriptine (2.5mg/day) for up to one week.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998556

Contacts
Contact: Johann Bauersachs, Prof. Dr. med. (0)511-532-3840 ext 0049 bauersachs.johann@mh-hannover.de
Contact: Denise Hilfiker-Kleiner, Prof. Dr. (0)511-532-2531 ext 0049 hilfiker.denise@mh-hannover.de

Locations
Germany
Hannover Medical School (MHH) Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Johann Bauersachs, Prof. Dr. med.    (0)511-532-3840 ext 0049    bauersachs.johann@mh-hannover.de   
Contact: Denise Hilfiker-Kleiner, Prof. Dr.    (0)511-532-2531 ext 0049    hilfiker.denise@mh-hannover.de   
Principal Investigator: Bauersachs Johann, Prof. Dr. med.         
Sponsors and Collaborators
Hannover Medical School
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Johann Bauersachs, Prof. Dr. Hannover Medical School, Hannover, Germany
Study Chair: Denise Hilfiker-Kleiner, Prof. Dr. Hannover Medical School, Hannover, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Denise Hilfiker-Kleiner, PhD, Authorized Representative of the Sponsor, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00998556     History of Changes
Other Study ID Numbers: PPCM
Study First Received: October 19, 2009
Last Updated: September 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Peripartum cardiomyopathy
Bromocriptine

Additional relevant MeSH terms:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases
Bromocriptine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014