RecruitingPhase 3NCT03593759

Cardiac Sarcoidosis Randomized Trial

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

160 participants

Start Date

Jan 15, 2019

Study Type

INTERVENTIONAL

Conditions

Sarcoidosis Cardiac Sarcoidosis

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methotrexate and a drug called Prednisone or Prednisolone for people with cardiac sarcoidosis and sarcoidosis. The study is currently recruiting participants at 31 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisone or Prednisolone

Oral prednisone/prednisolone tablet

DRUGMethotrexate

Oral, subcutaneous, or intramuscular methotrexate

Locations(31)

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

Auckland City Hospital

Auckland, Grafton, New Zealand

King's College Hospital NHS Foundation Trust

London, United Kingdom

Imperial College Healthcare Trust-NHS-Hammersmith Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03593759

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