Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
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).
⁃ (i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:
• advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
• significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
• non- sustained or sustained ventricular arrhythmia
• left ventricular dysfunction (LVEF \< 50%)
• right ventricular dysfunction (RVEF \< 40%)
⁃ AND
⁃ (ii) No alternative explanation for clinical features
⁃ AND
⁃ (iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging
⁃ AND ONE OR BOTH OF FOLLOWING
⁃ (iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac)
⁃ (v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy