Cardiac Sarcoidosis Multi-Center Prospective Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorOttawa Heart Institute Research Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)

Disqualifiers

unable or unwilling to provide informed consent

patients who are pregnant or lactating

patients with known claustrophobia

age < 18 years

Trial population

Electrophysiology Service patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: CS screened as underlying etiology

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

total mortality

Time frame
6 months and 60 months
2

cardiovascular mortality

Time frame
6 months and 60 months
3

heart failure hospitalization

Time frame
6 months and 60 months
4

change in LVEF from baseline

Time frame
6 months and 60 months

Other outcomes

Sponsors and contacts

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Ottawa Heart Institute Research Corporation

Lead sponsor

Ontario Ministry of Health and Long Term Care

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator