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Cardiac Sarcoidosis Randomized Trial
Sponsor: Ottawa Heart Institute Research Corporation
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).
Official title: Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2019-01-15
Completion Date
2025-12
Last Updated
2024-12-03
Healthy Volunteers
No
Conditions
Interventions
Prednisone or Prednisolone
Oral prednisone/prednisolone tablet
Methotrexate
Oral, subcutaneous, or intramuscular methotrexate
Locations (30)
Yale-New Haven Hospital
New Haven, Connecticut, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneota, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Hokkaido University
Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan
Chiba University
Chiba, Japan
University of Fukui
Fukui, Japan
St. Marrianna University
Kawasaki, Japan
Nagoya City University
Nagoya, Japan
National Cerebral and Cardiovascular Center (NCVC)
Osaka, Japan
Sapporo Medical University
Sapporo, Japan
Nippon Medical School
Tokyo, Japan
King's College Hospital NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare Trust-NHS-Hammersmith Hospital
London, United Kingdom