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No funding obtained.
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There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis. Corticosteroid therapy is advocated by some experts, but is based on small observational studies, with varied clinical response.
Objectives of this trial:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Prednisone 0.5 mg/Kg per day orally for 3 months |
|
| Placebo | Placebo Comparator | Matching placebo tablets(s) taken orally per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone 0.5 mg/Kg orally per day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure hospitalization and sustained ventricular arrhythmia | Considered a responder to steroid therapy if alive, no heart failure hospitalization and no sustained ventricular arrhythmia, and improvement in one or both of:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity by PET imaging |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Birnie, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Pablo B. Nery, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 3 months |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |