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

Primary Purpose

Peripartum Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bromocriptine
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripartum Cardiomyopathy focused on measuring Peripartum cardiomyopathy, Bromocriptine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hannover Medical School (MHH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bromocriptine

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2009
Last Updated
September 2, 2020
Sponsor
Hannover Medical School
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00998556
Brief Title
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
Acronym
PPCM
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripartum Cardiomyopathy
Keywords
Peripartum cardiomyopathy, Bromocriptine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bromocriptine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bromocriptine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up
Description
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
Secondary Outcome Measure Information:
Title
Combined endpoint of hospitalization for heart failure, eligibility for cardiac transplantation, cardiac transplantation, and mortality during 6 months follow-up
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Bauersachs, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Hannover, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Hilfiker-Kleiner, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Hannover, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Hannover Medical School (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34247489
Citation
Feyen E, Ricke-Hoch M, Van Fraeyenhove J, Vermeulen Z, Scherr M, Dugaucquier L, Viereck J, Bruyns T, Thum T, Segers VFM, Hilfiker-Kleiner D, De Keulenaer GW. ERBB4 and Multiple MicroRNAs That Target ERBB4 Participate in Pregnancy-Related Cardiomyopathy. Circ Heart Fail. 2021 Jul;14(7):e006898. doi: 10.1161/CIRCHEARTFAILURE.120.006898. Epub 2021 Jul 12.
Results Reference
derived
PubMed Identifier
28934837
Citation
Hilfiker-Kleiner D, Haghikia A, Berliner D, Vogel-Claussen J, Schwab J, Franke A, Schwarzkopf M, Ehlermann P, Pfister R, Michels G, Westenfeld R, Stangl V, Kindermann I, Kuhl U, Angermann CE, Schlitt A, Fischer D, Podewski E, Bohm M, Sliwa K, Bauersachs J. Bromocriptine for the treatment of peripartum cardiomyopathy: a multicentre randomized study. Eur Heart J. 2017 Sep 14;38(35):2671-2679. doi: 10.1093/eurheartj/ehx355.
Results Reference
derived
PubMed Identifier
26026286
Citation
Haghikia A, Podewski E, Berliner D, Sonnenschein K, Fischer D, Angermann CE, Bohm M, Rontgen P, Bauersachs J, Hilfiker-Kleiner D. Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy. Clin Res Cardiol. 2015 Nov;104(11):911-7. doi: 10.1007/s00392-015-0869-5. Epub 2015 May 31.
Results Reference
derived
Links:
URL
http://www.mh-hannover.de/index.php?id=10294&L=1
Description
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Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy

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