RecruitingPhase 3

Cardiac Sarcoidosis Randomized Trial

United States, Canada, Japan194 participantsStarted 2019-01-15

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Current or recent (within two months) non-topical treatment for sarcoidosis
. Current Oral/IV treatment of duration greater than 5 days
. Currently taking Methotrexate or Prednisone for another health condition
. Intolerance or contra-indication to Methotrexate or Prednisone
. Patient does not meet all of the above listed 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Summed perfusion rest score (SPRS) on FDG-PET scan

Timeframe: 6 months

Trial details

NCT IDNCT03593759

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

David H Birnie, MD

613-696-7269 dbirnie@ottawaheart.ca

View on ClinicalTrials.gov More Cardiac Sarcoidosis trials