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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.
- Source :
-
Clinical research in cardiology : official journal of the German Cardiac Society [Clin Res Cardiol] 2015 Nov; Vol. 104 (11), pp. 911-7. Date of Electronic Publication: 2015 May 31. - Publication Year :
- 2015
-
Abstract
- Background: Peripartum cardiomyopathy (PPCM) is an idiopathic heart disease that develops in the last month of pregnancy and/or the first months following delivery in previously healthy women and may lead to acute heart failure. A cleaved fragment of the nursing hormone prolactin is considered essential in the pathophysiology of PPCM. To date, no specific therapy has been tested for PPCM in a randomized controlled trial of adequate size.<br />Aims: The purpose of this trial is to investigate the safety of the dopamin-D2-receptor agonist bromocriptine and its effects on left ventricular (LV) function in women with PPCM.<br />Methods: This is an 11 center German trial with a prospective randomized controlled open-label design. The trial enrolls females with newly diagnosed PPCM according to European Society of Cardiology criteria with a LV ejection fraction (LVEF) <35 %. Patients are randomized 1:1 to either best supportive care (BSC) including standard heart failure therapy plus 8 weeks of bromocriptine therapy (2.5 mg b.i.d. for 14 days and 2.5 mg q.d. from day 15 to 56) or to BSC plus 1 week of low-dose bromocriptine (2.5 mg q.d.) with anticoagulant therapy at a prophylactic dose administered during the period of bromocriptine treatment in both groups. The primary endpoint is change in LVEF from baseline to 6 months follow-up as assessed by cardiac magnetic resonance imaging (or echocardiography if CMR is not tolerated). The secondary endpoints are hospitalization for worsening heart failure, heart transplantation, and all-cause mortality during follow-up or a combination of these endpoints. A total of 60 patients will be recruited (including 6 potential dropouts) giving a power of 0.9 for an expected LVEF change of 10.8 % between treatment groups at 6 months.<br />Perspective: This trial will provide important knowledge on potential benefits and safety of prolonged inhibition of prolactin release with bromocriptine in addition to standard heart failure therapy in newly diagnosed PPCM.<br />Trial Registration: ClinicalTrials.gov Identifier: NCT00998556.
- Subjects :
- Adult
Cardiomyopathies diagnosis
Female
Humans
Peripartum Period
Pregnancy
Pregnancy Complications, Cardiovascular diagnosis
Research Design
Survival Rate
Treatment Outcome
Ventricular Dysfunction, Left diagnosis
Young Adult
Bromocriptine administration & dosage
Cardiomyopathies drug therapy
Multicenter Studies as Topic
Pregnancy Complications, Cardiovascular drug therapy
Randomized Controlled Trials as Topic methods
Ventricular Dysfunction, Left drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1861-0692
- Volume :
- 104
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Clinical research in cardiology : official journal of the German Cardiac Society
- Publication Type :
- Academic Journal
- Accession number :
- 26026286
- Full Text :
- https://doi.org/10.1007/s00392-015-0869-5