Cardiac Sarcoidosis Randomized Trial
Key facts
- Where
- Ann Arbor, Boston, Columbus, Minneota, New Haven, New York, Pittsburgh, Richmond, and Salt Lake City, United StatesSee the 9 sites
- Phase
- Phase 3
Where in United States
- University of Michigan-Michigan Medicine Cardiovascular CenterAnn Arbor, United StatesContact: Todd Koelling, MDTaking people
- Tufts Medical CenterBoston, United StatesContact: Mili Mehta, MDTaking people
- The Ohio State University -Wexner Medical CenterColumbus, United StatesContact: Steven Kalbfleisch, MDTaking people
- University of MinnesotaMinneota, United StatesContact: C Shenoy, MDNot yet recruiting
- Yale New Haven HospitalNew Haven, United StatesContact: Edward Miller, MDTaking people
- Montefiore Medical CenterNew York, United StatesContact: Yogita Rochlani, MDTaking people
- Allegheny General HospitalPittsburgh, United StatesContact: Indu Poornima, MDTaking people
- Virginia Commonwealth UniversityRichmond, United StatesContact: Jordana Kron, MDTaking people
- University of UtahSalt Lake City, United StatesContact: Line Kemeyou, 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.