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 2026-11-04.
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.
271 studies on the registry are indexed under Sarcoidosis; 51 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 130 across 109 observational studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Electrophysiology Service patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To diagnose Clinically Manifest CS all following criteria must be met:
(i) Positive * 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Patients with active Clinically Manifest CS 2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS
Primary Outcome for ALL Patients
The primary outcome is a composite of cardiac death, aborted sudden cardiac death, sustained ventricular arrhythmia, heart failure hospitalization or cardiac transplantation. Heart failure hospitalization is defined as admission to hospital \> 24 hours and received treatment for heart failure. Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for ALL Patients
1\. Total mortality Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for ALL Patients
2\. Individual components of primary outcome (cardiac death, aborted sudden cardiac death, sustained ventricular arrhythmia, heart failure hospitalization or cardiac transplantation) Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
1\. Change in LVEF from baseline (%) Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
2\. Change in RVEF from baseline (%) Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
3\. Change in cardiac disease activity from pre-treatment to on treatment and post-treatment cessation as assessed by FDG-PET Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
4\. Atrial fibrillation burden (from ICD and/or pacemaker diagnostics) Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
5\. Ventricular arrhythmia burden, including PVC burden (from ICD diagnostics and/or pacemaker diagnostics) Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
6\. Appropriate ICD therapy Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
7\. Percentage (%) of ventricular pacing Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Manifest Disease
8\. AV nodal function Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Secondary Outcomes for Patients with Clinically Silent Disease and Control Patients
1\. Development of Clinically Manifest CS Primary and secondary endpoints will be assessed at various time intervals to be decided.
Time frame: Through study completion, on average 10 years
Started Aug 2012 (actual). Primary completion is estimated for Mar 2027, 175 months after the start.
Of 59 non-industry observational studies under Sarcoidosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 111. This study's planned 175 months is above that.
Counting every sponsor, half of 59 studies reached it within 49 months; a quarter within 20 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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