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

Cardiac sarcoidosis
All genders
person-wave 18+
Recruiting now


Principal Investigator: Jenica Upshaw

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).

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Easton Cummins

Study details

Inclusion Criteria
  • Left ventricular dysfunction (LVEF < 50%)
  • FDG-PET uptake suggestive of active cardiac sarcoidosis within two months of enrollment
  • Positive biopsy for Sarcoid (either endometrial biopsy or extra-cardiac)
Exclusion Criteria
  • Current or recent (within two months) treatment for sarcoidosis
  • Intolerance or contra-indication to Methotrexate or Prednisone
Study Requirements

The study is expected to last for 6 months with 5 to 6 research visits. There will be 2 blood collections; one at the beginning of the study and one at the end of the study. Each blood collection will take 3 tubes (18 ml or 1 tablespoon) of blood. Participants will be asked to complete the following tests throughout their study visits: 2 positron emission tomography (PET) scans, 2 electrocardiograms, 2 echocardiograms, 1 skin/muscle strength and neuropsychiatric assessment, 2 bone mineral density scans, 2 cardiac MRIs, 3 quality of life questionnaires. Participants will also be asked to document taking their medication in-between visits by filling out a drug diary.

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