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Recruiting NCT06943365

Role of Anti-TREK-1 Autoantibodies in SCVF

— Observational Short-coupled Ventricular Fibrillation Idiopathic Ventricular Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies, DPP6 risk haplotype.
Who it may be relevant to
Registry conditions: Short-coupled Ventricular Fibrillation, Idiopathic Ventricular Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Circulating Anti-TREK-1 Autoantibodies as Diagnostic and Prognostic Biomarkers in Short-Coupled Ventricular Fibrillation

Overview

Short-coupled ventricular fibrillation (SCVF) is a lethal, primary electrical disorder and an important cause of unexplained cardiac arrest.1 Recent work from our group suggests that a substantial proportion of SCVF cases is associated to circulating autoantibodies targeting TREK-1, a cardiac potassium channel, resulting in an abnormal gain-of-function which is the prerequisite for the SCVF phenotype.2 This proposal is a translational multicenter study to validate anti-TREK-1 autoantibodies as a diagnostic and prognostic biomarker in a large, diversified cohort of SCVF patients (Figure 1). Functional, cellular experiments in patient-derived hiPSC cardiomyocytes and Purkinje cells will be performed to explore the cell type-specific role of TREK-1 in arrhythmogenesis, while single-nuclear RNA sequencing (snRNA-seq) will allow us to establish the transcriptomic profile (Figure 1). These results will identify the cellular substrate for SCVF.

Detailed description

Please refer to the uploaded study protocol

Interventions

  • Other Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies
    Semiquantitative measure of circulating anti-TREK-1 autoantibodies in plasma of study participants using a peptid microarray
  • Genetic DPP6 risk haplotype
    Systematic genetic screening for the Dutch DPP6 risk haplotype in all study participants and correlation of results with the presence or absence of anti-TREK-1 autoantibodies

Primary outcome measures

  • Presence of anti-TREK-1 autoantibodies at three different time points [Time frame: 12 months]
Secondary outcome measures (2)
  • Time-dependent variability of plasma concentrations of anti-TREK-1 autoantibodies [Time frame: 12 months]
  • Impact of anti-TREK-1 autoantibodies on disease severity [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of SCVF as per current criteria
  • Willingness to provide written informed consent

Exclusion criteria

\- SCVF patients < age 18

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 4 centers
  • St-Paul's Hospital - University of British Columbia — Vancouver
  • PHRI — Hamilton
  • Ottawa Heart Center — Ottawa
  • Institut universitaire de cardiologie et pneumologie de Québec — Québec
Netherlands · 1 center
  • Amsterdam University Medical Center — Amsterdam

Publications

  • Steinberg C. Short-Coupled Ventricular Fibrillation. Card Electrophysiol Clin. 2023 Sep;15(3):331-341. doi: 10.1016/j.ccep.2023.05.004. Epub 2023 Jun 18. PMID 37558303
  • Steinberg C, Davies B, Mellor G, Tadros R, Laksman ZW, Roberts JD, Green M, Alqarawi W, Angaran P, Healey J, Sanatani S, Leather R, Seifer C, Fournier A, Duff H, Gardner M, McIntyre C, Hamilton R, Simpson CS, Krahn AD. Short-coupled ventricular fibrillation represents a distinct phenotype among latent causes of unexplained cardiac arrest: a report from the CASPER registry. Eur Heart J. 2021 Jul 31 PMID 34010395
  • Li J, Janin A, Patoughi M, Gaudreault N, Kis L, Moha Ou Maati H, Bosse Y, Steinberg C. Circulating Autoantibodies Targeting TREK-1 in Patients With Short-Coupled Ventricular Fibrillation. Circulation. 2024 Dec 10;150(24):1944-1954. doi: 10.1161/CIRCULATIONAHA.124.070284. Epub 2024 Sep 24. PMID 39315453

Identifiers

NCT: NCT06943365 · MP-10-2025-4338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗