NCT00000524

Myocarditis Treatment Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.

Detailed description

BACKGROUND: Heart failure due to myocarditis can be a devastating illness. At the same time, immunosuppressive therapy is associated with considerable risks of untoward side effects. Clinicians did not know whether, under what circumstances, or in what form, this hazardous treatment should be used in such critically ill patients. In addition, if immunosuppressive therapy was of benefit, then endomyocardial biopsy in patients suspected of having myocarditis was a justified procedure. The trial also provided information concerning the side effects of immuno-suppressive therapy in such patients. DESIGN NARRATIVE: Patients were randomized into two treatment arms consisting of conventional therapy alone for congestive heart failure or combined with a twenty-four week regimen of immunosuppressive therapy. Immunosuppressive therapy consisted of prednisone with either cyclosporine or azathioprine. The primary outcome measure was a change in the left ventricular ejection fraction at twenty-eight weeks. Secondary endpoints included survival, failures of therapy, requirements for conventional therapy, assessments of symptoms, myocardial histology, and arrhythmias. The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Myocarditis

Interventions

Type	Name	Description
DRUG	cyclosporine
DRUG	prednisone

Timeline

• Start date: 1986-07-01
• Completion: 1994-03-01
• First posted: 1999-10-28
• Last updated: 2023-04-18