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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Utah

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Myocarditis Drug: cyclosporine Drug: prednisone Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Study Start Date : July 1986
Actual Study Completion Date : March 1994

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, 18 years of age or older, with left ventricular failure and biopsy-documented myocarditis.

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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


Sponsors and Collaborators
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Jay Mason University of Utah

Publications:
ClinicalTrials.gov Identifier: NCT00000524     History of Changes
Other Study ID Numbers: 43
R01HL034744-04 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Myocarditis
Cardiovascular Diseases
Heart Diseases
Cardiomyopathies
Prednisone
Cyclosporins
Cyclosporine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors