Myocarditis Treatment Trial
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|ClinicalTrials.gov Identifier: NCT00000524|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Myocarditis||Drug: cyclosporine Drug: prednisone||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 1986|
|Actual Study Completion Date :||March 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000524
|OverallOfficial:||Jay Mason||University of Utah|