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Myocarditis Treatment Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00000524
First received: October 27, 1999
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Myocarditis
Drug: cyclosporine
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Utah:

Study Start Date: July 1986
Study Completion Date: March 1994
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000524

Sponsors and Collaborators
University of Utah
Investigators
Investigator: Jay Mason University of Utah