Short-coupled Ventricular FibrillationTRACK-VFNCT06943365
Role of Anti-TREK-1 Autoantibodies in SCVF
An observational study of Short-coupled Ventricular Fibrillation and Idiopathic Ventricular Fibrillation, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 5 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short-coupled Ventricular Fibrillation, Idiopathic Ventricular Fibrillation
- What is being tested?
- Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies and DPP6 risk haplotype
- How many people
- 300 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2025to 31 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort study of SCVF probands
Who may be able to join
- Age ≥ 18 years
- Diagnosis of SCVF as per current criteria
- Willingness to provide written informed consent
Who cannot join
- SCVF patients < age 18
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Canada4 sites, 3 recruiting
- Active, not recruiting
PHRI
Hamilton, Ontario
- Not yet recruiting
Ottawa Heart Center
Ottawa, Ontario
Simon Hansom, MD
- Recruiting
Institut universitaire de cardiologie et pneumologie de Québec
Québec, Quebec, G1V4G5
Steinberg Steinberg, MD, +4186568711, christian.steinberg@criucpq.ulaval.ca
- Not yet recruiting
St-Paul's Hospital - University of British Columbia
Vancouver, British Columbia
Andrew D Krahn, MD
Netherlands1 site
- Active, not recruiting
Amsterdam University Medical Center
Amsterdam
About this study
Official title: Circulating Anti-TREK-1 Autoantibodies as Diagnostic and Prognostic Biomarkers in Short-Coupled Ventricular Fibrillation
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.
Read the detailed description
Please refer to the uploaded study protocol
- Being tested
- Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies, DPP6 risk haplotype
- Keywords
- SCVF, anti-TREK-1 antibodies, IVF
- Medical subject headings
- Paroxysmal ventricular fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodiesOther
Semiquantitative measure of circulating anti-TREK-1 autoantibodies in plasma of study participants using a peptid microarray
DPP6 risk haplotypeGenetic
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
| Study group | Role | What they receive |
|---|---|---|
| SCVF | Probands with diagnosis of SCVF Receives: Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies; Genetic: DPP6 risk haplotype | |
| IVF | Otherwise unexplained idiopathic ventricular fibrillation Receives: Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies; Genetic: DPP6 risk haplotype | |
| Control group | Unaffected healthy individuals matched for age, sex and ethnicity Receives: Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of anti-TREK-1 autoantibodies at three different time points
Plasma concentrations of anti-TREK-1 autoantibodies (semiquantitative measure using a peptide microarray at three predefined time points
Measured: 12 months
Secondary outcomes (2)
Time-dependent variability of plasma concentrations of anti-TREK-1 autoantibodies
Repeat plasma sampling to assess the presence/absence of anti-TREK-1 autoantibodies and time-dependent variability of antibody expression
Measured: 12 months
Impact of anti-TREK-1 autoantibodies on disease severity
Correlation of the presence (plasma concentration) of anti-TREK-1 autoantibodies with recurrent VF, electrical storm and appropriate ICD therapies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Short-coupled Ventricular FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Steinberg, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Christian Steinberg, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943365
- Sponsor's protocol ID
- MP-10-2025-4338
- Acronym
- TRACK-VF
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37558303Steinberg 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;42(29):2827-2838. doi: 10.1093/eurheartj/ehab275.
PubMed 34010395Li 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.
PubMed 39315453
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Anti-TREK-1 Autoantibodies as Diagnostic and Prognostic Biomarkers in Short-Coupled Ventricular Fibrillation
- ClinicalTrials.gov ID
- NCT06943365
- Acronym / sponsor ID
- TRACK-VF / MP-10-2025-4338
- Keywords
- SCVF, anti-TREK-1 antibodies, IVF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCVF | – | Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies, Genetic: DPP6 risk haplotypeProbands with diagnosis of SCVF |
| IVF | – | Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodies, Genetic: DPP6 risk haplotypeOtherwise unexplained idiopathic ventricular fibrillation |
| Control group | – | Other: Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodiesUnaffected healthy individuals matched for age, sex and ethnicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort study of SCVF probands
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Diagnosis of SCVF as per current criteria
- Willingness to provide written informed consent
Key exclusion criteria (1 listed)
- SCVF patients < age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeat plasma screening for the presence or absence of anti-TREK-1 autoantibodiesSemiquantitative measure of circulating anti-TREK-1 autoantibodies in plasma of study participants using a peptid microarray | Other | Control group, IVF, SCVF |
| DPP6 risk haplotypeSystematic 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 | Genetic | IVF, SCVF |
Primary outcome
Presence of anti-TREK-1 autoantibodies at three different time points
Time frame: 12 months
Plasma concentrations of anti-TREK-1 autoantibodies (semiquantitative measure using a peptide microarray at three predefined time points
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 37558303Steinberg 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.
- Background: PubMed 34010395Steinberg 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;42(29):2827-2838. doi: 10.1093/eurheartj/ehab275.
- Background: PubMed 39315453Li 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Steinberg, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short-coupled Ventricular Fibrillation and Idiopathic Ventricular Fibrillation, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Sanchez, PhD (+14186568711, marina.sanchez@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of anti-TREK-1 autoantibodies at three different time points (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.