Myocarditis Treatment Trial

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000524
• Other study ID #: 43
• Secondary ID: R01HL034744-04
• Status: Completed
• Phase: Phase 2
• Start date: July 1986
• Est. completion date: March 1994

Study information

• Verified date: November 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1994
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Myocarditis

Intervention

Drug:
• cyclosporine

• prednisone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (6)

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. doi: 10.1093/eurheartj/16.suppl_o.162. — View Citation

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. doi: 10.1056/NEJM199508033330501. — View Citation

Mason JW, O'Connell JB. Clinical merit of endomyocardial biopsy. Circulation. 1989 May;79(5):971-9. doi: 10.1161/01.cir.79.5.971. — View Citation

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. doi: 10.1016/s0735-1097(10)80331-6. — View Citation

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

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. doi: 10.1002/sim.4780090126. — View Citation