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Major study aims to uncover hidden heart disease and test steroid treatment

NCT ID NCT01477359

Knowledge-focused Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 1,500 people with cardiac sarcoidosis—a condition where inflammation affects the heart—to learn how doctors currently diagnose and treat it. Researchers will also test whether corticosteroid therapy improves outcomes. The goal is to create better guidelines and reduce deaths from this often-missed disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
corticosteroids
What this could lead to
If successful, this study could provide clear guidelines for diagnosing and treating cardiac sarcoidosis, potentially reducing deaths and heart complications.
What could go wrong
This is an observational registry with a planned randomized trial; results are years away and may not change practice if the trial fails to show benefit or has low enrollment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2012

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Electrophysiology Service patients

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac sarcoidosis sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac sarcoidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier de l"Universite de Montreal-Hotel Dieu

    NOT_YET_RECRUITING

    Montreal, Quebec, H2W 1T8, Canada

  • Hamilton Health Sciences Centre

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hokkaido University

    RECRUITING

    Sapporo, 060-8638, Japan

  • Libin Cardiovascular Institute of Alberta

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Prairie Vascular Research Inc-Regina General Hospital

    RECRUITING

    Regina, Saskatchewan, S4P 0W5, Canada

  • QEII Health Sciences Center

    RECRUITING

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Southlake Regional Health Centre

    RECRUITING

    Newmarket, Ontario, L3Y 2P9, Canada

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.