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RECRUITING
NCT01477359

Cardiac Sarcoidosis Multi-Center Prospective Cohort

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

Summary

Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity. There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS. A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.

Official title: Cardiac Sarcoidosis Multi-Center Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2012-08

Completion Date

2025-12

Last Updated

2024-05-08

Healthy Volunteers

No

Locations (14)

Libin Cardiovascular Institute of Alberta

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de l"Universite de Montreal-Hotel Dieu

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Prairie Vascular Research Inc-Regina General Hospital

Regina, Saskatchewan, Canada

Hokkaido University

Sapporo, Japan