Cardiac Sarcoidosis Randomized Trial
Status: Recruiting
Conditions: Sarcoidosis
Location:
Montefiore Medical CenterOhio State University Medical Center
Tufts Medical Center
University of Michigan
University of Minnesota
University of Utah
Virginia Commonwealth University
Yale-New Haven Hospital
City/State:
New Haven, Connecticut
Boston, Massachusetts
Ann Arbor, Michigan
New York, New York
Columbus, Ohio
Pittsburgh, Pennsylvania
Salt Lake City, Utah
Richmond, Virginia
Contact Information:
David H Birnie, MD
613-696-7269
[email protected]
Janine Ryan, BAH, CCRP
613-696-7000 ext 17077
[email protected]
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).
Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:
Everywhere but Japan:
- Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
- Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD 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
