Ohio State University Medical Center

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:

  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 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
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