Abstract | BACKGROUND: 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.
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Authors | D M McNamara, R Holubkov, R C Starling, G W Dec, E Loh, G Torre-Amione, A Gass, K Janosko, T Tokarczyk, P Kessler, D L Mann, A M Feldman |
Journal | Circulation
(Circulation)
Vol. 103
Issue 18
Pg. 2254-9
(May 08 2001)
ISSN: 1524-4539 [Electronic] United States |
PMID | 11342473
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Immunoglobulins, Intravenous
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Topics |
- Acute Disease
- Adult
- Biopsy
- Cardiomyopathy, Dilated
(complications, diagnosis, drug therapy)
- Cohort Studies
- Disease-Free Survival
- Female
- Follow-Up Studies
- Humans
- Immunization, Passive
- Immunoglobulins, Intravenous
(therapeutic use)
- Male
- Myocarditis
(complications, diagnosis, drug therapy)
- Myocardium
(pathology)
- Prognosis
- Prospective Studies
- Stroke Volume
(drug effects)
- Treatment Outcome
- Ventricular Function, Left
(drug effects)
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