Cardiac Sarcoidosis Randomized Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
9 states
Healthy volunteers
No
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About this study
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).
Sponsor: Ottawa Heart Institute Research Corporation
You may qualify if…
- ✓ (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
You may not qualify if…
- ✕ 1. Current or recent (within two months) non-topical treatment for sarcoidosis
- ✕ 2. Current Oral/IV treatment of duration greater than 5 days
- ✕ 3. Currently taking Methotrexate or Prednisone for another health condition
- ✕ 4. Intolerance or contra-indication to Methotrexate or Prednisone
- ✕ 5. Patient does not meet all of the above listed inclusion criteria
- ✕ 6. Patient is unable or unwilling to provide informed consent
- ✕ 7. Patient is included in another randomized clinical trial
- ✕ 8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
Where it's recruiting
New Haven
Boston
Ann Arbor
Minneota
New York
Columbus
Pittsburgh
Salt Lake City
Richmond
Source: ClinicalTrials.gov · NCT03593759 · last updated 2026-07-10