title: Controlled trial of intravenous immune globulin in recent-onset dilated cardiomyopathy.
abstract: BACKGROUND
  This prospective placebo-controlled trial was designed to determine whether intravenous immune globulin (IVIG) improves left ventricular ejection fraction (LVEF) in adults with recent onset of idiopathic dilated cardiomyopathy or myocarditis.
  
  
  RESULTS
  Sixty-two patients (37 men, 25 women; mean age +/-SD 43.0+/-12.3 years) with recent onset (</=6 months of symptoms) of dilated cardiomyopathy and LVEF </=0.40 were randomized to 2 g/kg IVIG or placebo. All underwent an endomyocardial biopsy before randomization, which revealed cellular inflammation in 16%. The primary outcome was change in LVEF at 6 and 12 months after randomiz. Overall, LVEF improved from 0.25+/-0.08 to 0.41+/-0.17 at 6 months (P<0.001) and 0.42+/-0.14 (P<0.001 versus baseline) at 12 months. The increase was virtually identical in patients receiving IVIG and those given placebo (6 months: IVIG 0.14+/-0.12, placebo 0.14+/-0.14; 12 months: IVIG 0.16+/-0.12, placebo 0.15+/-0.16). Overall, 31 (56%) of 55 patients at 1 year had an increase in LVEF >/=0.10 from study entry, and 20 (36%) of 56 normalized their ejection fraction (>/=0.50). The transplant-free survival rate was 92% at 1 year and 88% at 2 years.
  
  
  CONCLUSIONS
  These results suggest that for patients with recent-onset dilated cardiomyopathy, IVIG does not augment the improvement in LVEF. However, in this overall cohort, LVEF improved significantly during follow-up, and the short-term prognosis remains favorable.
authors.affiliation: Cardiovascular Institute of the University of Pittsburgh Medical Center, Pittsburgh, PA, USA. mcnamaradm@msx.upmc.edu
authors.forename: D M
authors.initials: DM
authors.lastname: McNamara
authors.forename: R
authors.initials: R
authors.lastname: Holubkov
authors.forename: R C
authors.initials: RC
authors.lastname: Starling
authors.forename: G W
authors.initials: GW
authors.lastname: Dec
authors.forename: E
authors.initials: E
authors.lastname: Loh
authors.forename: G
authors.initials: G
authors.lastname: Torre-Amione
authors.forename: A
authors.initials: A
authors.lastname: Gass
authors.forename: K
authors.initials: K
authors.lastname: Janosko
authors.forename: T
authors.initials: T
authors.lastname: Tokarczyk
authors.forename: P
authors.initials: P
authors.lastname: Kessler
authors.forename: D L
authors.initials: DL
authors.lastname: Mann
authors.forename: A M
authors.initials: AM
authors.lastname: Feldman
mesh_terms: D000208:Acute Disease; D000328:Adult; D001706:Biopsy; D002311:Cardiomyopathy, Dilated / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007116:Immunization, Passive; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008297:Male; D009205:Myocarditis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D009206:Myocardium / Q000473:pathology; D011379:Prognosis; D011446:Prospective Studies; D013318:Stroke Volume / Q000187:drug effects; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects
chemical_list: D016756:Immunoglobulins, Intravenous