Myocarditis Treatment Trial (Immunosuppressive Theapy for Myocarditis) - Myocarditis Treatment

Description:

Cyclosporine, imuran and steroids for LV function in myocarditis.

Hypothesis:

Immunosuppressive therapy with cyclosporine, imuran and steroids improves left ventricular function in patients with myocarditis.

Study Design

Study Design:

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
Female: 38
Mean Ejection Fraction: 24

Patient Populations:

Heart failure onset during two years preceding enrollment
Left ventricular ejection fraction < 45%
Histologic diagnosis (Dallas criteria) of myocarditis

Exclusions:

Coronary artery disease
Any other specific cause of cardiomyopathy

Primary Endpoints:

Left ventricular ejection fraction (at 28 weeks)

Secondary Endpoints:

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.

Drug/Procedures Used:

Cyclosporine
Azathioprine
Prednisone

Principal Findings:

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.

Interpretation:

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).

References:

1. N Engl J Med 1995; 333:269-275 Final results

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Cyclosporine, Steroids, Prednisone, Azathioprine, Ventricular Function, Left, Immunosuppressive Agents, Heart Failure, Myocarditis, Stroke Volume


< Back to Listings