NCT00000524

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1986

Longer than P75 for phase_2 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1986

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1994

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 18, 2023

Status Verified

November 1, 2013

First QC Date

October 27, 1999

Last Update Submit

April 13, 2023

Conditions

Cardiovascular DiseasesHeart DiseasesMyocarditis

Interventions

cyclosporineDRUG
prednisoneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, 18 years of age or older, with left ventricular failure and biopsy-documented myocarditis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 2653662BACKGROUND

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

    PMID: 2660415BACKGROUND

  • 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.

    PMID: 2345835BACKGROUND

  • 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.

    PMID: 2229805BACKGROUND

  • 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.

    PMID: 7596370BACKGROUND

  • 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.

    PMID: 8682088BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesMyocarditis

Interventions

CyclosporinePrednisone

Condition Hierarchy (Ancestors)

Cardiomyopathies

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Jay Mason

    University of Utah

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1986

Study Completion

March 1, 1994

Last Updated

April 18, 2023

Record last verified: 2013-11