NCT01477359

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
2 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

13.3 years

First QC Date

November 10, 2011

Last Update Submit

May 7, 2024

Conditions

Cardiac Sarcoidosis

Keywords

Sarcoidosis

Outcome Measures

Primary Outcomes (2)

  • Clinically Manifest Patients

    "Clinically improved" if they are alive and not had a heart transplant and have not had heart failure hospitalization and no sustained VT/VF and meet one or more of following (i) No sustained VT (if presented with sustained VT) (ii) Improvement in LV function (defined as 10% decrease in LV end systolic volume or 5% absolute increase in LVEF) (iii) Resolution of conduction system disease (if presented with sustained heart block) failure hospitalization and have not had sustained VT and one or both of: a. LV function improvement (defined as 10% decrease in LV end systolic volume) b. Resolution of conduction system disease.

    On active therapy for 6 months

  • 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%).

    9 years

Secondary Outcomes (8)

  • total mortality

    6 months and 60 months

  • cardiovascular mortality

    6 months and 60 months

  • heart failure hospitalization

    6 months and 60 months

  • change in LVEF from baseline

    6 months and 60 months

  • change in disease activity as assessed by PET imaging

    6 months and 60 months

  • +3 more secondary outcomes

Study Arms (1)

CS screened as underlying etiology

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Electrophysiology Service patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Libin Cardiovascular Institute of Alberta

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Centre Hospitalier de l"Universite de Montreal-Hotel Dieu

Montreal, Quebec, H2W 1T8, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Prairie Vascular Research Inc-Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

RECRUITING

Hokkaido University

Sapporo, 060-8638, Japan

RECRUITING

Related Publications (2)

  • Weng W, Wiefels C, Chakrabarti S, Nery PB, Celiker-Guler E, Healey JS, Hruczkowski TW, Quinn FR, Promislow S, Medor MC, Spence S, Odabashian R, Alqarawi W, Juneau D, de Kemp R, Leung E, Beanlands R, Birnie D. Atrial Arrhythmias in Clinically Manifest Cardiac Sarcoidosis: Incidence, Burden, Predictors, and Outcomes. J Am Heart Assoc. 2020 Sep;9(17):e017086. doi: 10.1161/JAHA.120.017086. Epub 2020 Aug 20.

    PMID: 32814465DERIVED

  • Martineau P, Pelletier-Galarneau M, Juneau D, Leung E, Nery PB, de Kemp R, Beanlands R, Birnie D. Imaging Cardiac Sarcoidosis With FLT-PET Compared With FDG/Perfusion-PET: A Prospective Pilot Study. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2280-2281. doi: 10.1016/j.jcmg.2019.06.020. Epub 2019 Aug 14. No abstract available.

    PMID: 31422126DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Frozen plasma, serum and buffy coat.

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • David Birnie, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Pablo Nery, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Rob Beanlands, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janine E Ryan, BA(H), CCRP

CONTACT

613-696-7000jryan@ottawaheart.ca

David Birnie, MD

CONTACT

613-696-7269dbirnie@ottawaheart.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 22, 2011

Study Start

August 1, 2012

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

JP(1)CA(13)