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Cardiac Sarcoidosis Randomized Trial

RecruitingPhase 3Ages 18 Years - anyAllOttawa Heart Institute Research Corporation
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Prednisone or Prednisolone
  • Methotrexate
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Where

31 sites
Yale-New Haven Hospital
New Haven, United States
Tufts Medical Center
Boston, United States
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, United States
University of Minnesota
Minneota, United States
Montefiore Medical Center
New York, United States
The Ohio State University Wexner Medical Center
Columbus, United States
Allegheny General Hospital
Pittsburgh, United States
University of Utah
Salt Lake City, United States

โ€ฆand 23 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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