(Circulation. 2001;103:2254.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Controlled Trial of Intravenous Immune Globulin in Recent-Onset Dilated Cardiomyopathy
From the Cardiovascular Institute of the University of Pittsburgh Medical Center (D.M.M., R.H., K.J., T.T., A.M.F.), Pittsburgh, Pa; Department of Epidemiology (R.H.), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa; Cleveland Clinic Foundation (R.C.S.), Cleveland, Ohio; Massachusetts General Hospital (G.W.D.), Boston, Mass; Hospital of the University of Pennsylvania (E.L.), Philadelphia, Pa; Baylor Methodist Hospital (G.T.-A.), Houston, Tex; Mount Sinai Medical Center (A.G.), New York, NY; Johns Hopkins University School of Medicine (P.K.), Baltimore, Md; and Cardiology Section of the Department of Medicine (D.L.M.), Veterans Administration Medical Center and The Baylor College of Medicine, Houston, Tex.
Correspondence to Dennis M. McNamara, MD, Director, Heart Failure Section, University of Pittsburgh Medical Center, S-558 Scaife Hall, 200 Lothrop St, Pittsburgh, PA 15213. E-mail mcnamaradm{at}msx.upmc.edu
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.
Methods and
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.
Key Words: cardiomyopathy • immune system • myocarditis • biopsy
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