Cardiac Sarcoidosis Randomized Trial (CHASM-CS-RCT)
Cardiac Sarcoidosis, Sarcoidosis
About this trial
This is an interventional treatment trial for Cardiac Sarcoidosis focused on measuring Cardiac Sarcoidosis, Prednisone (or Prednisolone), Methotrexate
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) 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:
- Current or recent (within two months) non-topical treatment for sarcoidosis
- 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
Sites / Locations
- Yale-New Haven HospitalRecruiting
- Tufts Medical CenterRecruiting
- University of Michigan-Michigan Medicine Cardiovascular CenterRecruiting
- University of Minnesota
- Montefiore Medical CenterRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- Allegheny General Hospital
- University of UtahRecruiting
- Virginia Commonwealth UniversityRecruiting
- Libin Cardiovascular Institute of AlbertaRecruiting
- St. Paul's Hospital
- Eastern Health Health Sciences CentreRecruiting
- QE II Health Sciences CentreRecruiting
- St. Joseph's Healthcare CentreRecruiting
- London Health Sciences CentreRecruiting
- University of Ottawa Heart InstituteRecruiting
- University Health Network
- Montreal Heart InstituteRecruiting
- CIUSSS-Hopital du Sacre-Coeur de MontrealRecruiting
- Institut universitaire de cardiologie et de pneumologie de Québec-Université LavalRecruiting
- CIUSSS de l'Estrie - CHUS - Hôpital FleurimontRecruiting
- Hokkaido UniversityRecruiting
- Chiba UniversityRecruiting
- University of Fukui
- St. Marrianna University
- Nagoya City UniversityRecruiting
- National Cerebral and Cardiovascular Center (NCVC)Recruiting
- Sapporo Medical UniversityRecruiting
- Nippon Medical SchoolRecruiting
- King's College Hospital NHS Foundation Trust
- Imperial College Healthcare Trust-NHS-Hammersmith Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Prednisone (or Prednisolone)
Methotrexate
[Dose everywhere except Japan] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg) [Dose in Japan] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months
[Dose everywhere except Japan] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid 2 mg po daily for 6 months. [Dose in Japan] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.