(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Cardiac Sarcoidosis Randomized Trial
Status: Recruiting
Location: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital
Conditions: Montefiore Medical Center, Ohio 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]
Brief 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).
Detailed Description:
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