Cardiac Sarcoidosis Randomized Trial

RECRUITING

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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).

Conditions:

🦠 Cardiac Sarcoidosis 🦠 Sarcoidosis

🗓️ Study Start (Actual) 15 January 2019

🗓️ Primary Completion (Estimated) December 2025

✅ Study Completion (Estimated) December 2025

👥 Enrollment (Estimated) 194

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 New Haven, Connecticut, United States

📍 Boston, Massachusetts, United States

📍 Ann Arbor, Michigan, United States

📍 Minnesota, Minnesota, United States

📍 New York, New York, United States

📍 Columbus, Ohio, United States

📍 Pittsburgh, Pennsylvania, United States

📍 Salt Lake City, Utah, United States

📍 Richmond, Virginia, United States

📍 Calgary, Alberta, Canada

📍 Vancouver, British Columbia, Canada

📍 St. John's, Newfoundland and Labrador, Canada

📍 Halifax, Nova Scotia, Canada

📍 Hamilton, Ontario, Canada

📍 London, Ontario, Canada

📍 Ottawa, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Montreal, Quebec, Canada

📍 Quebec City, Quebec, Canada

📍 Sherbrooke, Quebec, Canada

📍 Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan

📍 Chiba, Japan

📍 Fukui, Japan

📍 Kawasaki, Japan

📍 Nagoya, Japan

📍 Osaka, Japan

📍 Sapporo, Japan

📍 Tokyo, Japan

📍 London, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

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) FDG-PET uptake suggestive of active CS within two months of enrollment AND Myocardial Perfusion Imaging (MPI) completed (confirmed by PET core lab read)
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. Currently taking Methotrexate or Prednisone for another health condition
3. Intolerance or contra-indication to Methotrexate or Prednisone
4. Patient does not meet all of the above listed inclusion criteria
5. Patient is unable or unwilling to provide informed consent
6. Patient is included in another randomized clinical trial
7. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
8. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
9. Breastfeeding
10. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
11. Patients for whom the investigator believes that the trial is not in the interest of the patient

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 27 June 2018
First Submitted that Met QC Criteria 10 July 2018
First Posted 20 July 2018

Study Record Updates

Last Update Submitted that Met QC Criteria 24 July 2023
Last Update Posted 25 July 2023
Last Verified July 2023