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European Heart Journal Advance Access originally published online on June 25, 2009
European Heart Journal 2009 30(16):1995-2002; doi:10.1093/eurheartj/ehp249
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study

Andrea Frustaci1,2,*, Matteo A. Russo3,4 and Cristina Chimenti1,2,4

1 Cardiovascular and Respiratory Sciences Department, La Sapienza University, Viale del Policlinico 155, 00161 Rome, Italy
2 Molecular and Cellular Cardiology Laboratory, National Institute for Infectious Diseases ‘Lazzaro Spallanzani’, Rome, Italy
3 Experimental Medicine Department, La Sapienza University, Rome, Italy
4 IRCCS San Raffaele La Pisana, Rome, Italy

Received 11 February 2009; revised 8 May 2009; accepted 29 May 2009; online publish-ahead-of-print 25 June 2009.

* Corresponding author. Tel: +39 0655170575, Fax: +39 0655170577, Email: biocard{at}inmi.it

See page 1936 for the editorial comment on this article (doi:10.1093/eurheartj/ehp172)

Aims: To evaluate the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy.

Methods and results: 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.

Conclusion: 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.

Key Words: Inflammatory cardiomyopathy • Immunosuppressive therapy • Heart Failure • Ejection Fraction • NYHA class


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