Controlled trial of intravenous immune globulin in recent-onset dilated cardiomyopathy

Background-This prospective placebo-controlled trial was designed to determ ine whether intravenous immune globulin (IVIG) improves left ventricular ej ection fraction (LVEF) in adults with recent onset of idiopathic dilated ca rdiomyopathy or myocarditis. Methods and Results-Sixty-two patients (37 men, 25 women: mean age +/-SD 43 .0+/-12.3 years) with recent onset (less than or equal to6 months of sympto ms) of dilated cardiomyopathy and LVEF less than or equal to0.40 were rando mized to 2 g/kg IVIG or placebo. All underwent an endomyocardial biopsy bef ore randomization, which revealed cellular inflammation in 16%. The primary outcome was change in LVEF at 6 and 12 months after randomization. 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 virtual ly 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 i n LVEF greater than or equal to0.10 from study entry, and 20 (36%) of 56 no rmalized their ejection fraction (greater than or equal to0.50). The transp lant-free survival rate was 92% at 1 year and 88% at 2 years. Conclusions-These results suggest that for patients with recent-onset dilat ed cardiomyopathy, IVIG does not augment the improvement in LVEF. However, in this overall cohort, LVEF improved significantly during follow-up, and t he short-term prognosis remains favorable.