Abstract
To evaluate the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. This randomized, double-blind, placebo-controlled study included 85 patients with myocarditis and chronic (>6 months) heart failure unresponsive to conventional therapy, with no evidence of myocardial viral genomes. Patients received either prednisone 1 mg kg(-1) day(-1) for 4 weeks followed by 0.33 mg kg(-1) day(-1) for 5 months and azathioprine 2 mg kg(-1) day(-1) for 6 months (43 patients, Group 1) or placebo (42 patients, Group 2) in addition to conventional therapy for heart failure. Primary outcome was the 6 month improvement in left-ventricular function. Group 1 showed a significant improvement of left-ventricular ejection fraction and a significant decrease in left-ventricular dimensions and volumes compared with baseline. None of Group 2 patients showed improvement of ejection fraction, that significantly worsened compared with baseline. No major adverse reaction was registered as a result of immunosuppression. These data confirm the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Lack of response in 12% of cases suggests the presence of not screened viruses or mechanisms of damage and inflammation not susceptible to immunosuppression.
Highlights
The role of immunosuppression in the treatment of myocarditis is still debated because of the controversial results obtained both in children[1,2] and adults[3,4] presenting with either cardiac arrhythmias[5] or heart failure.[6]
These data indicate in the absence of cardiac viral genomes a prerequisite for the clinical use of immunosuppression while suggest a potential impact of antiviral agents for patients with virus-positive inflammatory cardiomyopathy
According with our previous retrospective study, treatment of virus negative inflammatory cardiomyopathy patients with immunosuppressive therapy for 6 months leads to an improvement in ejection fraction (EF) in more than 85% of cases.[8]
Summary
These data confirm the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Lack of response in 12% of cases suggests the presence of not screened viruses or mechanisms of damage and inflammation not susceptible to immunosuppression. Inflammatory cardiomyopathy † Immunosuppressive therapy † Heart Failure † Ejection Fraction † NYHA class
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