An observational study in Cardiac Sarcoidosis, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 14 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Ottawa Heart Institute Research Corporation · Observational
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.
Baseline assessment of Clinically Manifest CS patients consists of: history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers within 2 months of the PET scan, cardiac MRI and possibly a signal average ECG and biopsy (encouraged-either endomyocardial or extra-cardiac).
Follow-up and clinical management of clinically manifest patients diagnosed with CS will occur at 3-6 months with a repeat FDG-PET scan and blood biomarkers. Follow-up will then be annually with an echo and ECG. Treatment with steroids/immunosuppressants and device therapy will be at the discretion of the treating physician.
Baseline assessment of patients diagnosed with extra-cardiac sarcoidosis and being screened for CS consists of: history, echocardiogram, ECG, holter, chest CT scan, biopsy, and cardiac MRI (CMR). If the CMR is suggestive of CS the patient will be have a FDG-PET scan done and be followed as a Clinically Silent patient. They will be contacted every 2 years. If the CMR is negative the patient will be followed as a extra-cardiac sarcoidosis patient with no evidence of CS and be in the control group. They will be contacted at 5 years and at the time of study completion.
All patients will be followed until the last patient recruited has been followed for 4 years.
The occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.
There will be 2 imaging core labs. The PET core lab will be located at UOHI under the direction of Dr. Robert Beanlands. The CMR core lab will be under the direction of Dr. Mathias Friedrich (McGill University). All scans will be read in the core labs by physicians who are blinded to the clinical details of the patients.
The Biomarker core lab will be at The University of Ottawa Heart Institute under the leadership of Dr P Liu.
Electrophysiology Service patients
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:
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
Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control
Exclusion Criteria:
1. Patients with active Clinically Manifest CS 2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS
Clinically Silent and Control Patients
Cardiac death or cardiac transplantation or sustained VT/VF or sustained second or third degree AV block or development of clinical congestive heart failure (with documented LVEF \< 50%).
Time frame: 9 years
total mortality
Time frame: 6 months and 60 months
cardiovascular mortality
Time frame: 6 months and 60 months
heart failure hospitalization
Time frame: 6 months and 60 months
change in LVEF from baseline
Time frame: 6 months and 60 months
change in disease activity as assessed by PET imaging
comparing pre-treatment to 6 month scans
Time frame: 6 months and 60 months
Atrial Fibrillation burden
from defibrillator diagnostics
Time frame: 6 months and 60 months
Ventricular arrhythmia burden
from defibrillator diagnostics
Time frame: 6 months and 60 months
% of ventricular pacing
Time frame: 6 months and 60 months
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Ottawa Heart Institute Research Corporation