Recruiting

Observational Study

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT01477359

Conditions

Cardiac Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cardiac Sarcoidosis

Study ID

NCT01477359

Start date

Aug, 2012

Status verified date

Jun, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

  • 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

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

  • 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%)

Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control

Exclusion Criteria:

  • unable or unwilling to provide informed consent
  • patients who are pregnant or lactating
  • patients with known claustrophobia
  • age < 18 years

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

CS screened as underlying etiology

1. Patients with active Clinically Manifest CS
2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS

Primary outcome measure

  • Clinically Manifest Patients [ Time Frame: On active therapy for 6 months ]
  • Clinically Silent and Control Patients [ Time Frame: 9 years ]

Central Contacts and Locations

Central contacts

Janine E Ryan, BA(H), CCRP

613-696-7000jryan@ottawaheart.ca

David Birnie, MD

613-696-7269dbirnie@ottawaheart.ca

Locations

Libin Cardiovascular Institute of Alberta

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Principal Investigator:

Russell Quinn, MD

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Principal Investigator:

Tomascz Hruczkowski, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Principal Investigator:

Shanta Chakrabarti, MD

QEII Health Sciences Center

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Principal Investigator:

Ciorsti MacIntyre, MD

Hamilton Health Sciences Centre

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Jeff Healey, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Principal Investigator:

Lorne Gula, MD

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Principal Investigator:

Bernice Tsang, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Janine E Ryan, BA H

613-696-7000jryan@ottawaheart.ca

Tammy Knight

613-696-7000tknight@ottawaheart.ca

Principal Investigator:

David Birnie, MD

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Andrew Ha, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Principal Investigator:

Lena Rivard, MD

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Principal Investigator:

Martin L Bernier, MD

Prairie Vascular Research Inc-Regina General Hospital

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

Contacts

Kendra Townsend

Ktownsend.pvri@gmail.com

Principal Investigator:

Andrea Lavoie, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Sarcoidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-06-24.