Observing cardiac sarcoidosis in patients

Cardiac Sarcoidosis Multi-Center Prospective Cohort Study

This study looks at patients with cardiac sarcoidosis and those at risk for it to see how the disease progresses and how treatments like corticosteroids affect them.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 14 sites (Calgary, Alberta and 13 other locations)
• Trial ID: NCT01477359 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess patients with clinically manifest cardiac sarcoidosis (CS) and those with extra-cardiac sarcoidosis being screened for CS. It involves comprehensive baseline evaluations including medical history, imaging tests like echocardiograms and FDG-PET scans, and biomarker analysis. Patients will be followed up at intervals to monitor the progression of the disease and the effects of treatment, if applicable. The study seeks to fill the gap in understanding the clinical course of CS and the impact of corticosteroid therapy.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with clinically manifest cardiac sarcoidosis or those with extra-cardiac sarcoidosis being screened for cardiac involvement.

Not a fit: Patients without a diagnosis of sarcoidosis or those who do not meet the inclusion criteria for clinically manifest or clinically silent cardiac sarcoidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management of cardiac sarcoidosis, potentially reducing morbidity and mortality associated with the condition.

How similar studies have performed: While there is limited prospective data on cardiac sarcoidosis, previous studies have highlighted the importance of early diagnosis and treatment, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

To diagnose Clinically Manifest CS all following criteria must be met:

(i) Positive biopsy\* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features:

* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
* non- sustained or sustained ventricular arrhythmia
* ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS

To diagnose clinically silent CS all of the following criteria must be met

(i) Biopsy proven extra-cardiac sarcoidosis

AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis

AND (iii) CMR suggestive of cardiac sarcoidosis

AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following

* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
* non- sustained or sustained ventricular arrhythmia
* ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%)

Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control

Exclusion Criteria:

* unable or unwilling to provide informed consent
* patients who are pregnant or lactating
* patients with known claustrophobia
* age \< 18 years

Where this trial is running

Calgary, Alberta and 13 other locations

• Libin Cardiovascular Institute of Alberta — Calgary, Alberta, Canada (Recruiting)
• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
• QEII Health Sciences Center — Halifax, Nova Scotia, Canada (Recruiting)
• Hamilton Health Sciences Centre — Hamilton, Ontario, Canada (Recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada (Recruiting)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Centre Hospitalier de l"Universite de Montreal-Hotel Dieu — Montreal, Quebec, Canada (Not_yet_recruiting)
• McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
• Prairie Vascular Research Inc-Regina General Hospital — Regina, Saskatchewan, Canada (Recruiting)
• Hokkaido University — Sapporo, Japan (Recruiting)

Study contacts

• Principal investigator: David Birnie, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Janine E Ryan, BA(H), CCRP

Conditions Cardiac Sarcoidosis; Sarcoidosis