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

Study Description

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 Design

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Myocarditis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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

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OverallOfficial:	Jay Mason	University of Utah

More Information

Publications:

Mason JW, O'Connell JB. Clinical merit of endomyocardial biopsy. Circulation. 1989 May;79(5):971-9. Review.

O'Connell JB, Mason JW. Diagnosing and treating active myocarditis. West J Med. 1989 Apr;150(4):431-5. Review.

O'Connell JB, Mason JW. The applicability of results of streamlined trials to clinical practice: the Myocarditis Treatment Trial. Stat Med. 1990 Jan-Feb;9(1-2):193-6; discussion 196-7.

Neumann DA, Burek CL, Baughman KL, Rose NR, Herskowitz A. Circulating heart-reactive antibodies in patients with myocarditis or cardiomyopathy. J Am Coll Cardiol. 1990 Nov;16(6):839-46.

Mason JW, O'Connell JB, Herskowitz A, Rose NR, McManus BM, Billingham ME, Moon TE. A clinical trial of immunosuppressive therapy for myocarditis. The Myocarditis Treatment Trial Investigators. N Engl J Med. 1995 Aug 3;333(5):269-75.

Hahn EA, Hartz VL, Moon TE, O'Connell JB, Herskowitz A, McManus BM, Mason JW. The Myocarditis Treatment Trial: design, methods and patients enrollment. Eur Heart J. 1995 Dec;16 Suppl O:162-7.

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ClinicalTrials.gov Identifier:	NCT00000524
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:

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Cardiovascular Diseases Heart Diseases Myocarditis Cardiomyopathies Cyclosporine Prednisone Cyclosporins 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

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