Cardiac Sarcoidosis Randomized Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this 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).
Eligibility criteria
Qualifiers
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%)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prednisone or Prednisolone
- Methotrexate
Treatment groups
194 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ottawa Heart Institute Research Corporation
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov