Cardiac Sarcoidosis Randomized Trial

Recruiting Phase 3 Interventional Study
Cardiac Sarcoidosis Sarcoidosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Ottawa Heart Institute Research Corporation · Other
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About This Trial
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 Predni…
Trial Locations
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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 su…
Contacts

David H Birnie, MD

613-696-7269

dbirnie@ottawaheart.ca

CONTACT

Janine Ryan, BAH, CCRP

613-696-7000

jryan@ottawaheart.ca

CONTACT