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Distribution of Cell-cell Junction Proteins in Arrhythmic Disorders

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v8
  2. Minor Enrollment target: 18 to 26v7
  3. Notable Results first posted: Feb 17, 2025v6 Show 5 more changesShow less
    • Enrollment target: estimated 800 to confirmed 18
    • Primary endpoint revised
    • Primary completion date changed from estimate of Oct 2024 to Mar 30, 2024
    • Study completion date: Oct 2025 to Jun 30, 2027
    • Secondary endpoints revised (2)
  4. Notable Primary completion date: Oct 2022 to Oct 2024
    • Study completion date: Oct 2023 to Oct 2025
    v5
  5. Minor 2 versions Re-verified since Mar 16, 2021, no change to tracked fieldsv3-v4
  6. Minor Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Every week in the UK, 12 apparently healthy and fit individuals under the age of 35 die suddenly, a tragic event known as sudden cardiac death (SCD). The investigators have shown that heritable cardiac disorders affect the distribution of proteins at the cardiac cell-cell junctions, the areas where cardiac cells are mechanically and electrically coupled. This knowledge has helped the investigators diagnose specific heart disorders in individuals thus reducing the risk and incidence of SCD. Yet, the primary material required is a heart sample. A heart biopsy is an invasive process that comes with risks and is not performed unless absolutely necessary. And it is impossible to obtain a heart sample from an individual that may be carrying a disease-causing mutation (and hence be at risk of SCD) but does not yet show evidence of disease manifestation. The investigators recently showed that buccal cells show changes in protein distribution equivalent to those exhibited by the heart,hence providing them with a surrogate tissue for the myocardium. The investigators aim to use buccal smears as a means to identify those at risk of SCD. Patients regularly seen at the cardiology clinics at St. George's Hospital can participate in the study. The investigators shall take a buccal smear simply by rubbing a soft brush at the inside of their cheek and smearing it on a slide. Most individuals willing to participate in the study will only have to provide the investigators with a sample once. However, in selected cases (for instance, if the patients show disease progression or have a change in medication) they may be asked to provide the investigators with a subsequent sample during one of their scheduled follow-up visits. The process takes only a few seconds, is totally risk- and pain-free and it is anticipated to have great implications in diagnosis and patient management.
Trial Details
NCT Number NCT04257994
Lead Sponsor St. George's Hospital, London
Conditions
(from sponsor)
Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Cardiac Channelopathy
Related terms Arrhythmias, Cardiac, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov