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Cardiac Sarcoidosis Randomized Trial
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: (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 AND (iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging AND ONE OR BOTH OF FOLLOWING (iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac) (v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy Exclusion Criteria: 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 9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment) 10. Breastfeeding 11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study 12. Patients for whom the investigator believes that the trial is not in the interest of the patient
About the 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).
What is being tested
- Prednisone or Prednisolone (drug)
- Methotrexate (drug)
Sponsor: Ottawa Heart Institute Research Corporation · Participants: 160 · Started: Jan 15, 2019
Contact the study team
- David H Birnie, MD · Phone: 613-696-7269
- Janine Ryan, BAH, CCRP · Phone: 613-696-7000
Official record on ClinicalTrials.gov — NCT03593759
Locations in the U.S.
| Connecticut | Yale-New Haven Hospital, New Haven |
| Massachusetts | Tufts Medical Center, Boston |
| Michigan | University of Michigan-Michigan Medicine Cardiovascular Center, Ann Arbor |
| Minnesota | University of Minnesota, Minneota (Not yet recruiting) |
| New York | Montefiore Medical Center, New York |
| Ohio | The Ohio State University Wexner Medical Center, Columbus |
| Pennsylvania | Allegheny General Hospital, Pittsburgh |
| Utah | University of Utah, Salt Lake City |
| Virginia | Virginia Commonwealth University, Richmond |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.