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Myocarditis Treatment Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000524
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Utah
  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

Information from the National Library of Medicine

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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.
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000524     History of Changes
Other Study ID Numbers: 43
R01HL034744-04 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
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