Myocarditis Treatment Trial

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status and phase

Completed
Phase 2

Conditions

Myocarditis
Cardiovascular Diseases
Heart Diseases

Treatments

Drug: cyclosporine
Drug: prednisone

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000524
R01HL034744-04 (U.S. NIH Grant/Contract)
43

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men and women, 18 years of age or older, with left ventricular failure and biopsy-documented myocarditis.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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