Cardiac Sarcoidosis Randomized Trial

Phase 3 Recruiting 160 enrolled Ottawa Heart Institute Research Corporation Canadian Institutes of Health Research (CIHR) · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2019-01-15
Primary completion: 2026-12
Completion: 2026-12

Publications

Birnie D, Beanlands RSB, Nery P, Aaron SD, Culver DA, DeKemp RA, Gula L, Ha A, Healey JS, Inoue Y, Judson MA, Juneau D, Kusano K, Quinn R, Rivard L, Toma M, Varnava A, Wells G, Wickremasinghe M, Kron J. Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT). Am Heart J. 2020 Feb;220:246-252. doi: 10.1016/j.ahj.2019.10.003. Epub 2019 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	15 mg	Oral
Subject	Methotrexate	Small molecule	20 mg	Oral
Subject	Prednisolone	Other / unclassified	0.5 mg/kg	Oral
Subject	Prednisolone	Other / unclassified	5 mg	Oral
Subject	Prednisone	Other / unclassified	0.5 mg/kg	Oral
Subject	Prednisone	Other / unclassified	5 mg	Oral

Cardiac Sarcoidosis Randomized Trial

Summary

Timeline

Publications

Drugs

Indications