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New heart test could predict sudden cardiac death risk

NCT ID NCT06188689

Diagnosis Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study aims to develop a new clinical test to diagnose Calcium Release Deficiency Syndrome (CRDS), a rare inherited heart condition that increases the risk of sudden cardiac arrest. Researchers will use a pacing procedure to measure heart wave changes in 400 participants, including those with CRDS and similar conditions. The goal is to replace current lab-based genetic testing with a simpler, faster diagnostic method.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

Feb 2023

Expected to finish

Mar 2028

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Cohort 1: Calcium Release Deficiency Syndrome (CRDS) Cases Inclusion criteria: • Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing Exclusion criteria: • Unable to provide informed consent Cohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases Inclusion criteria: * Satisfy a clinical phenotype consistent with the Expert Consensus Statement * Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic/pathogenic CASQ2 variants Exclusion criteria: * Unable to provide informed consent * Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers Cohort 3: Survivors of Unexplained Cardiac Arrest (UCA) Inclusion criteria: * Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test * Undergone genetic testing that includes screening of RyR2\* Exclusion criteria: * Unable to provide informed consent * Use of a QT prolonging medication at the time of the burst pacing maneuvers * Among survivors of UCA that possess a rare RyR2 variant in the absence of a CPVT phenotype, in vitro functional testing will be performed in order to confirm it is not loss- or gain-of-function (and will be arranged through the laboratory of Dr. Wayne Chen at the University of Calgary). Cohort 4: SVT controls Inclusion criteria: • Undergoing an invasive electrophysiology study Exclusion criteria: * Ventricular cardiomyopathy * Ventricular pre-excitation * Long QT syndrome * Use of a QT prolonging medication at the time of the EP study * Use of a Class I or Class III anti-arrhythmic drug at the time of the EP study * Known obstructive coronary artery disease (existing coronary stenosis \>50%) * Unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac arrest catecholaminergic polymorphic ventricular tachycardia combined immunodeficiency due to CRAC channel dysfunction Death, Sudden, Cardiac

As listed by the trial registrant

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

Calcium release deficiency syndrome (CRDS)

How to take part

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

  1. The places running it

    20 sites in 7 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

  • Aarhus University Hospital

    RECRUITING

    Aarhus, DK-8200 N, Denmark

  • Alberta Health Services

    RECRUITING

    Edmonton, Alberta, T6G 2C8, Canada

  • Antwerp University Hospital

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, New Aquitaine, 33404, France

  • Children's & Women's Health Centre of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • London Health Sciences Centre - University Hospital

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Montréal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • Oxford University Hospitals

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • The University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6T 1Z3, Canada

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 1N4, Canada

  • University of California

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

More trials for these conditions

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