NCT00998556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

5.8 years

First QC Date

October 19, 2009

Last Update Submit

September 2, 2020

Conditions

Peripartum Cardiomyopathy

Keywords

Peripartum cardiomyopathyBromocriptine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Combined endpoint of hospitalization for heart failure, eligibility for cardiac transplantation, cardiac transplantation, and mortality during 6 months follow-up

    6 months

Study Arms (2)

Bromocriptine

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

BromocriptineDRUG

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.

Bromocriptine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

  • 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.

    PMID: 34247489DERIVED

  • 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.

    PMID: 28934837DERIVED

  • 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.

    PMID: 26026286DERIVED

Related Links

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Pregnancy Complications, CardiovascularPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiomyopathiesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsErgolinesHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Johann Bauersachs, Prof. Dr.

    Hannover Medical School, Hannover, Germany

    PRINCIPAL INVESTIGATOR

  • Denise Hilfiker-Kleiner, Prof. Dr.

    Hannover Medical School, Hannover, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Authorized Representative of the Sponsor

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

June 1, 2010

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

September 7, 2020

Record last verified: 2020-09

Locations

DE(1)