Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Ottawa Heart Institute Research Corporation
Summary
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Description
Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either: Everywhere but Japan: 1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or 2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid OD (exact dose and directions at physician) for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP In Japan: 1. Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months or 2. Methotrexate 5-20mg po, sc or IM once w…