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Cardiac Sarcoidosis Randomized Trial

RECRUITING
I'm interested

18 years and over
This study is NOT accepting healthy volunteers
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:

• 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
• Patient does not meet all of the above listed inclusion criteria
• 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

DRUG: Prednisone or Prednisolone, DRUG: Methotrexate

Cardiac Sarcoidosis, Sarcoidosis

Cardiac Sarcoidosis, Prednisone (or Prednisolone), Methotrexate

David H Birnie, MD - dbirnie@ottawaheart.ca
Kron, Jordana
PHASE3
HM20014180
NCT03593759
See this study on ClinicalTrials.gov

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