Atrial Arrhythmias in Clinically Manifest Cardiac Sarcoidosis: Incidence, Burden, Predictors, and Outcomes.
Willy Weng, Christiane Wiefels, Santabhanu Chakrabarti...
https://pubmed.ncbi.nlm.nih.gov/32814465/Actively Recruiting
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-06-24
1500
Participants Needed
14
Research Sites
456 weeks
Total Duration
This research aims to better understand cardiac sarcoidosis CS, a condition where sarcoidosis affects the heart, causing serious heart problems like conduction disease, cardiomyopathy, and ventricular tachycardia. Many patients with CS remain undiagnosed, leading to significant health risks. There are no clear treatment guidelines, and corticosteroid therapy is commonly used but not well studied. This multi-center prospective cohort study, led by a Canadian research group, seeks to improve diagnosis, treatment, and outcomes for CS patients. Participants will be divided into two groups those with clinically manifest CS and those with extra-cardiac sarcoidosis being screened for cardiac involvement. Baseline assessments include medical history, heart imaging tests echocardiogram, ECG, cardiac MRI, CT scan, FDG-PET, blood biomarkers, and possibly biopsy. Follow-up visits occur every 3 to 6 months for clinically manifest patients with repeated imaging and blood tests, then annually with echocardiogram and ECG. Patients with silent CS are followed every two years, while those with no cardiac involvement are contacted at 5 years and study completion. Treatments like steroids, immunosuppressants, and device therapy are managed by the treating physician. Throughout the study, researchers will monitor clinical outcomes such as mortality, heart failure hospitalizations, heart function changes, and arrhythmia burden. Imaging core labs will independently review scans without clinical information to ensure unbiased results. Biomarker analysis will be performed at a dedicated lab. All participants will be followed for at least four years after the last patient enrolls, allowing detailed tracking of disease progression and treatment effects over time.
CONDITIONS
Cardiac Sarcoidosis Multi-Center Prospective Cohort
J
Janine E Ryan, BA(H), CCRP
D
David Birnie, MD
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Ottawa Heart Institute Research Corporation
Lead Sponsor
Ontario Ministry of Health and Long Term Care
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 months
Participants undergo initial evaluations including medical history, heart imaging (echocardiogram, ECG, cardiac MRI, chest CT, FDG-PET), blood tests, and possibly biopsy.
1 to 2 visits
Duration - Up to 4 years
Participants with active cardiac sarcoidosis receive follow-up visits every 3 to 6 months with repeat imaging and biomarker tests, then annually with echocardiogram and ECG.
Regular visits every 3 to 6 months initially, then annually
Duration - Up to 4 years
Participants with clinically silent cardiac sarcoidosis or no cardiac involvement are contacted every 2 to 5 years for monitoring and assessments.
Contacts every 2 to 5 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Willy Weng, Christiane Wiefels, Santabhanu Chakrabarti...
https://pubmed.ncbi.nlm.nih.gov/32814465/Patrick Martineau, Matthieu Pelletier-Galarneau, Daniel Juneau...
https://pubmed.ncbi.nlm.nih.gov/31422126/Ottawa Heart Institute Research Corporation
Lead Sponsor
Ontario Ministry of Health and Long Term Care
Collaborating Sponsor