RecruitingPhase 3

Cardiac Sarcoidosis Randomized Trial

United States194 participantsStarted 2019-01-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Current or recent (within two months) non-topical treatment for sarcoidosis
✕. Current Oral/IV treatment of duration greater than 5 days
✕. 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

What they're measuring

Summed perfusion rest score (SPRS) on FDG-PET scan

Timeframe: 6 months

Trial details

NCT IDNCT03593759

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

David H Birnie, MD

613-696-7269 dbirnie@ottawaheart.ca

View on ClinicalTrials.gov More Cardiac Sarcoidosis trials