Myocarditis Treatment Trial (Immunosuppressive Theapy for Myocarditis) - Myocarditis Treatment
Cyclosporine, imuran and steroids for LV function in myocarditis.
Immunosuppressive therapy with cyclosporine, imuran and steroids improves left ventricular function in patients with myocarditis.
Patients Screened: 2,233
Patients Enrolled: 111
NYHA Class: I= (15%), II= (35%), III=(40%), IV =(10%)
Mean Follow Up: 7 months (up to 4.3 years for mortality)
Mean Patient Age: 42
Mean Ejection Fraction: 24
Heart failure onset during two years preceding enrollment
Left ventricular ejection fraction < 45%
Histologic diagnosis (Dallas criteria) of myocarditis
Coronary artery disease
Any other specific cause of cardiomyopathy
Left ventricular ejection fraction (at 28 weeks)
Survival (mortality endpoint reached with either death or cardiac transplantation)
Evaluation of changes over time on biopsy, intensity of conventional heart failure therapy, and immunological markers of inflammation.
Entire group had improvement in left ventricular ejection fraction from 25% to 34% (p =0.001) but no differences existed between groups.
Positive independent predictors of ejection fraction at 28 weeks were:
No significant differences in survival between groups (p = 0.96)
High overall mortality rate; 20% at 1 year and 56% at 4.3 years.
Only 64% of original 111 patients were felt to have myocarditis meeting the Dallas criteria when reviewed by the pathology panel.
No beneficial effect of immunosuppressive therapy (as tested) in myocarditis was found. This trial was limited by the small number of patients with documented myocarditis and a question of accuracy of diagnosis in 36%. Results also indicate that histopathological diagnosis is not common in those suspected clinically of having myocarditis (10% in this study).
1. N Engl J Med 1995; 333:269-275 Final results
Keywords: Cyclosporine, Steroids, Prednisone, Azathioprine, Ventricular Function, Left, Immunosuppressive Agents, Heart Failure, Myocarditis, Stroke Volume
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