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CHASM-RCT


Title Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT).
Therapeutic Area Cardiac Sarcoidosis
Principal Investigator Amanda Vest, MBBS, MPH
Min Age 18 Years
Gender Any
Contact Easton Cummins
617-636-8417
ecummins@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03593759

Overview

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).

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.