Cardiac Sarcoidosis Randomized Trial
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Ottawa Heart Institute Research Corporation
194 participants
Jan 15, 2019
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria20
- (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
- 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
- Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
- Breastfeeding
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Patients for whom the investigator believes that the trial is not in the interest of the patient
Exclusion Criteria4
- 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
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Interventions
Oral prednisone/prednisolone tablet
Oral, subcutaneous, or intramuscular methotrexate
Locations(30)
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NCT03593759