Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.
| Condition | Intervention |
|---|---|
|
Myocarditis |
Drug: Muromonab-CD3 Drug: Cyclosporine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Giant Cell Myocarditis Treatment Trial Pilot Study |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | July 2004 |
Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Idiopathic heart failure and/or arrhythmia of less than 3 months duration
- Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
- Negative pregnancy test
Exclusion criteria:
- Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)
- Pregnant
- Any contraindication to immunosuppression
- Allergy to cyclosporine or muromonab-CD3
- Creatinine greater than 2.5 mg/dL
- AST or ALT greater than 3 times upper limit of normal
- Other severe concurrent disease that would preclude study
- Unreliable or uncooperative subject
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Leslie T. Cooper, M.D. 507-284-3680 cooper.leslie@may.edu | |
| Principal Investigator: Leslie T. Cooper, M.D. | |
| Principal Investigator: | Leslie T Cooper, MD | Mayo Clinic |
More Information
No publications provided by FDA Office of Orphan Products Development
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00027443 History of Changes |
| Other Study ID Numbers: | FD-R-1986-01, FD-R-001986-0 |
| Study First Received: | December 5, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by FDA Office of Orphan Products Development:
|
Giant Cell Myocarditis |
Additional relevant MeSH terms:
|
Heart Diseases Myocarditis Cardiomyopathies Cardiovascular Diseases Cyclosporins Cyclosporine Muromonab-CD3 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013