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Evaluation of A Clinical Diagnostic Test for CRDS

ConditionCalcium Release Deficiency Syndrome (CRDS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPopulation Health Research Institute

About this trial

Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Unable to provide informed consent

Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers

Trial design

Design model

Single group

Treatments tested in this trial

  • Pacing

    Diagnostic test

    1. Ventricular 10 beat burst at 500ms (120bpm) 2. Ventricular 10 beat burst at 400ms (150bpm) 3. Atrial 10 beat burst at 500ms (120bpm) 4. Atrial 10 beat burst at 400ms (150bpm).

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: PacingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ΔT-wave amplitude value

T-wave amplitude on first post-pause sinus beat subtracted by the T-wave amplitude on the last sinus beat prior to pacing

Time frame
At time of pacing maneuver
2

ΔQT value

Absolute QT value on first post-pause sinus beat subtracted by the absolute QT value on the last sinus beat prior to pacing

Time frame
At time of pacing maneuver

Secondary outcomes

1

Absolute QT value

Absolute QT value on first post-pause sinus beat

Time frame
At time of pacing maneuver
2

Absolute T-wave amplitude

Absolute T-wave amplitude on first post-pause sinus beat

Time frame
At time of pacing maneuver

Other outcomes

Sponsors and contacts

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Population Health Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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