Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS- RCT)


This is a Prospective, open-label, non-inferiority, randomized controlled trial (1:1 randomization) with blinded end-point analysis comparing the use of Prednisone versus Prednisone plus Methatrexate in the treatment of Cardiac Sarcoidosis.

I'm interested

18 Years to old
Inclusion Criteria:
(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) FDG-PET uptake suggestive of active CS within two months of enrollment (confirmed by PET core lab read) 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
Exclusion Criteria:
Current or recent (within two months) non-topical treatment for sarcoidosis Currently taking Methotrexate or Prednisone for another health condition Intolerance or contra-indication to Methotrexate or Prednisone Patient does not meet all of the above listed inclusion criteria Patient is unable or unwilling to provide informed consent Patient is included in another randomized clinical trial Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment) Breastfeeding Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study Patients for whom the investigator believes that the trial is not in the interest of the patient

Cardiac Sarcoidosis, Sarcoidosis

Cardiac Sarcoidosis, Methotrexate, Prednisone (or Prednisolone)

Michelle Pitt -
Chetan Shenoy
Phase III
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