Cardiac Sarcoidosis Randomized Trial
Key facts
- Where
- Calgary, Halifax, Hamilton, London, Montreal, Ottawa, Québec, Sherbrooke, St. John's, and Vancouver, CanadaSee the 11 sites
- Phase
- Phase 3
Where in Canada
- Libin Cardiovascular Institute of AlbertaCalgary, CanadaContact: Russell Quinn, MDTaking people
- QE II Health Sciences CentreHalifax, CanadaContact: Doug Hayami, MDTaking people
- St. Joseph's Healthcare CentreHamilton, CanadaContact: Nathan Hambly, MDTaking people
- London Health Sciences CentreLondon, CanadaContact: Nikolaos Tzemos, MDTaking people
- CIUSSS-Hopital du Sacre-Coeur de MontrealMontreal, CanadaContact: Leila Laroussi, MDTaking people
- Montreal Heart InstituteMontreal, CanadaContact: Genevieve Giraldeau, MDTaking people
- University of Ottawa Heart InstituteOttawa, CanadaContact: David H Birnie, MDTaking people
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université LavalQuébec, CanadaContact: Mario Senechal, MDTaking people
- CIUSSS de L'Estrie - CHUS - Hopital FleurimontSherbrooke, CanadaContact: Felix Ayala-Paredes, MDTaking people
- Eastern Health - Health Sciences CentreSt. John's, CanadaContact: Stephen Duffett, MDTaking people
- St. Paul's HospitalVancouver, CanadaContact: Mustafa Toma, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ottawa Heart Institute Research Corporation
- Trial code
- NCT03593759
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
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).
Inclusion: (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: Currently taking Methotrexate or Prednisone for another health condition; Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment); Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study; Current or recent (within two months) non-topical treatment for sarcoidosis; Current Oral/IV treatment of duration greater than 5 days; 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; Breastfeeding; Patients for whom the investigator believes that the trial is not in the interest of the patient.