Cardiac Sarcoidosis Randomized Trial

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Jul 10, 2018

Keywords

ClinConnect Summary

The Cardiac Sarcoidosis Randomized Trial is a study looking to compare two treatments for patients diagnosed with cardiac sarcoidosis, a condition where tiny clumps of immune cells form in the heart, affecting its function. The trial is testing whether a combination of low-dose Prednisone (or Prednisolone) and Methotrexate can work just as well as the standard higher dose of Prednisone (or Prednisolone) but with fewer side effects and a better quality of life for patients.

To be eligible for this trial, participants should be between the ages of 65 and 74 and have specific heart-related issues caused by cardiac sarcoidosis, such as significant heart rhythm problems or reduced heart function. They must also have undergone certain imaging tests showing signs of active disease and may need to have a positive biopsy for sarcoidosis. Participants can expect to receive one of the two treatment options and will be monitored closely throughout the study. It's important to note that individuals currently receiving other treatments for sarcoidosis or those with certain health conditions may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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