Cardiac Sarcoidosis Randomized Trial

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Methotrexate; Prednisolone; Prednisone

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) FDG-PET uptake suggestive of active CS within two months of enrollment (confirmed by PET core lab read)

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. Currently taking Methotrexate or Prednisone for another health condition

3. Intolerance or contra-indication to Methotrexate or Prednisone

4. Patient does not meet all of the above listed inclusion criteria

5. Patient is unable or unwilling to provide informed consent

6. Patient is included in another randomized clinical trial

7. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia

8. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)

9. Breastfeeding

10. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study

11. Patients for whom the investigator believes that the trial is not in the interest of the patient