1500 Participants Needed

Cardiac Sarcoidosis Multi-Center Prospective Cohort

(CHASM-CS Trial)

Recruiting at 14 trial locations
KM
DB
JE
Overseen ByJanine E Ryan, BA(H), CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
Must be taking: Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

PN

Pablo Nery, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

RB

Rob Beanlands, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

DB

David Birnie, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months
Multiple visits for baseline assessments

Baseline Assessment

Baseline assessment of Clinically Manifest CS patients includes history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers, cardiac MRI, and possibly a signal average ECG and biopsy.

2 months

Treatment

Treatment with steroids/immunosuppressants and device therapy at the discretion of the treating physician.

6 months

Follow-up

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.

4 years
Annual visits

Long-term Follow-up

All patients will be followed until the last patient recruited has been followed for 4 years. Clinically Silent patients will be contacted every 2 years, and extra-cardiac sarcoidosis patients will be contacted at 5 years and at the time of study completion.

9 years

What Are the Treatments Tested in This Trial?

Interventions

  • Corticosteroid Therapy
  • Implantation of a defibrillator

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Ontario Ministry of Health and Long Term Care

Collaborator

Trials
92
Recruited
108,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+
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