Cardiac Sarcoidosis Randomized Trial

  • STATUS
    Recruiting
  • End date
    Dec 21, 2024
  • participants needed
    194
  • sponsor
    Ottawa Heart Institute Research Corporation
Updated on 21 April 2021
methotrexate
prednisone
lymphadenopathy
pulmonary sarcoidosis
cardiac sarcoidosis

Summary

Prospective randomized controlled trial comparing low dose Prednisone/Methotrexate combination to standard dose Prednisone in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.

The Investigators hypothesize that low dose Prednisone/Methotrexate combination will be as effective as standard dose Prednisone, and result in significantly better quality of life and less toxicity than standard dose Prednisone.

Description

Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive

either
  1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
  2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP

Methotrexate will be initiated at a dose of 15 mg once a week and increased to 20 mg once a week after 4 weeks if tolerated. In case of Methotrexate-induced side-effects general guidelines will be provided, however specific management will be left to the treating physicians. Folic acid will be taken to help reduce methotrexate side-effects.

Prior to randomization and study treatment all subjects will have the following baseline tests done: baseline safety blood work; FDG-PET scan with myocardial perfusion imaging; ECG; echo; and a bone mineral density scan. Cardiac MRI (CMR) is optional but strongly encouraged. Blood will be obtained for biomarker core-lab analysis. Biomarkers to be assayed will include highly sensitive Troponin I. Samples will be stored for future novel biomarker discovery. Quality of LIfe (QOL) questionnaires (KSQ, SAT and SF-36) will be completed prior to treatment start.

After therapy initiation subjects will be seen at 4 weeks, 8 weeks (methotrexate arm only), and 12 weeks, with a final visit at 6 months. Safety bloodwork and assessment for medication side effects, using a medication side-effect questionnaire, will be completed at all visits. At 12 weeks QOL questionnaires will be completed. The primary endpoint will be assessed at 6-months, when FDG-PET with myocardial perfusion imaging, ECG, echo, bone mineral density scan, QOL questionnaires, blood for biomarkers and device interrogation will be done. CMR may be repeated. Skin, muscle strength testing and neuropsychiatric assessment will be completed at 6 months as part of the composite glucocorticoid toxicity index.

After the 6 month visit. further management will be at the treating physician's discretion. Details of the physicians planned treatment following the 6-month PET scan will be collected.

Standardized protocols for all aspects of FDG-PET scans (i.e. patient preparation, image acquisition, image processing, transfer to the core lab and analysis at core lab) will be followed.

Details
Condition Lymphoproliferative Disorder, Sarcoidosis, Cardiac Sarcoidosis, Lymphoproliferative disorders, sarcoid
Treatment methotrexate, prednisone
Clinical Study IdentifierNCT03593759
SponsorOttawa Heart Institute Research Corporation
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

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
Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
Breastfeeding
Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
Patients for whom the investigator believes that the trial is not in the interest of the patient

Exclusion Criteria

Current or recent (within two months) non-topical treatment for sarcoidosis
Currently taking Methotrexate or Prednisone for another health condition
Intolerance or contra-indication to Methotrexate or Prednisone
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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