Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000524
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
1999-10-27
Brief Title:
Myocarditis Treatment Trial
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis
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 QueryViewReport QVR System
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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL034744-04 | NIH | None | httpsreporternihgovquickSearchR01HL034744-04 |