title: 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.
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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00998556.
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. haghikia.arash@mh-hannover.de.
authors.forename: Arash
authors.initials: A
authors.lastname: Haghikia
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Edith
authors.initials: E
authors.lastname: Podewski
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Dominik
authors.initials: D
authors.lastname: Berliner
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Sonnenschein
authors.affiliation: Department of Cardiology and Angiology, University Hospital Muenster, Muenster, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Fischer
authors.affiliation: Department of Internal Medicine I, Comprehensive Heart Failure Center, University Hospital of Wuerzburg, Würzburg, Germany.
authors.forename: Christiane E
authors.initials: CE
authors.lastname: Angermann
authors.affiliation: Department of Internal Medicine III, University Hospital of Saarland, Homburg/Saar, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Röntgen
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Johann
authors.initials: J
authors.lastname: Bauersachs
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Denise
authors.initials: D
authors.lastname: Hilfiker-Kleiner
mesh_terms: D000328:Adult; D001971:Bromocriptine / Q000008:administration & dosage*; D009202:Cardiomyopathies / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D058725:Peripartum Period; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000175:diagnosis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D015996:Survival Rate; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D001971:Bromocriptine
keywords: Bromocriptine; Heart failure; Peripartum cardiomyopathy; Prolactin