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Trial NCT00000524

Resource URI: http://static.linkedct.org/resource/trials/NCT00000524
PropertyValue
linkedct:brief_title Myocarditis Treatment Trial
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8501>
linkedct:criteria Men and women, 18 years of age or older, with left ventricular failure and biopsy-documented myocarditis.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000524
rdfs:label Trial NCT00000524
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000524
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 43
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/26187>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000524>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/38548>
linkedct:reference <http://static.linkedct.org/resource/reference/38885>
linkedct:reference <http://static.linkedct.org/resource/reference/39499>
linkedct:reference <http://static.linkedct.org/resource/reference/39524>
linkedct:reference <http://static.linkedct.org/resource/reference/40050>
linkedct:reference <http://static.linkedct.org/resource/reference/45317>
linkedct:reference <http://static.linkedct.org/resource/reference/50107>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date July 1986
linkedct:study_design Treatment, Randomized, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
rdf:type linkedct:trials
linkedct:verification_date January 2000