Cardiac Sarcoidosis Randomized Trial

Recruiting now · Phase 3

Conditions studied: Cardiac Sarcoidosis, Sarcoidosis

In brief

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).

Key facts

Study ID

NCT03593759

Run by

Ottawa Heart Institute Research Corporation

People needed

160

Starts

2019-01-15

Expected to finish

2026-12-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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

You may not qualify if…

• 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

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan-Michigan Medicine Cardiovascular Center — Ann Arbor, Michigan, United States (enrolling)
• Nagoya City University — Nagoya, Japan (enrolling)
• National Cerebral and Cardiovascular Center (NCVC) — Osaka, Japan (enrolling)
• Sapporo Medical University — Sapporo, Japan (enrolling)
• Nippon Medical School — Tokyo, Japan (enrolling)
• Auckland City Hospital — Auckland, Grafton, New Zealand (enrolling)
• Montefiore Medical Center — New York, New York, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Libin Cardiovascular Institute of Alberta — Calgary, Alberta, Canada (enrolling)
• St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
• Eastern Health Health Sciences Centre — St. John's, Newfoundland and Labrador, Canada (enrolling)
• QE II Health Sciences Centre — Halifax, Nova Scotia, Canada (enrolling)
• St. Joseph's Healthcare Centre — Hamilton, Ontario, Canada (enrolling)
• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• CIUSSS-Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada (enrolling)
• Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval — Québec, Quebec, Canada (enrolling)
• CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont — Sherbrooke, Quebec, Canada (enrolling)
• Hokkaido University — Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan (enrolling)

Full record on ClinicalTrials.gov

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