Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

Cardiac Sarcoidosis Randomized Trial

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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).

Who May Be Eligible (Plain English)

Who May Qualify: (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 Who Should NOT Join This Trial: 1. Current or recent (within two months) non-topical treatment for sarcoidosis 2. Current Oral/IV treatment of duration greater than 5 days 3. Currently taking Methotrexate or Prednisone for another health condition 4. Intolerance or contra-indication to Methotrexate or Prednisone 5. Patient does not meet all of the above listed inclusion criteria 6. Patient is unable or unwilling to provide willing to sign a consent form 7. Patient is included in another randomized clinical trial 8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia 9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment) 10. Breastfeeding 11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study 12. Patients for whom the investigator believes that the trial is not in the interest of the patient Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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: 1. Current or recent (within two months) non-topical treatment for sarcoidosis 2. Current Oral/IV treatment of duration greater than 5 days 3. Currently taking Methotrexate or Prednisone for another health condition 4. Intolerance or contra-indication to Methotrexate or Prednisone 5. Patient does not meet all of the above listed inclusion criteria 6. Patient is unable or unwilling to provide informed consent 7. Patient is included in another randomized clinical trial 8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia 9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment) 10. Breastfeeding 11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study 12. Patients for whom the investigator believes that the trial is not in the interest of the patient

Treatments Being Tested

DRUG

Prednisone or Prednisolone

Oral prednisone/prednisolone tablet

DRUG

Methotrexate

Oral, subcutaneous, or intramuscular methotrexate

Locations (20)

Yale-New Haven Hospital
New Haven, Connecticut, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneota, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada