Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
223 participants
INTERVENTIONAL
2015-04-30
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Mutation Carriers
Whole-exome sequencing (WES) Dermal biopsy Gastro-intestinal questionnaire
Dermal biopsy
Skin biopsy
Gastro-intestinal questionnaire
Pagi-Sym, Bristol Stool Chart, gastrointestinal symptom rating scale (GSRS)
Whole-exome sequencing
Whole-exome sequencing (WES)
Non-Mutation Carriers
Whole-exome sequencing (WES) Gastro-intestinal questionnaire
Gastro-intestinal questionnaire
Pagi-Sym, Bristol Stool Chart, gastrointestinal symptom rating scale (GSRS)
Whole-exome sequencing
Whole-exome sequencing (WES)
Spouse
Whole-exome sequencing (WES) 12-Lead ECG
Whole-exome sequencing
Whole-exome sequencing (WES)
Interventions
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Dermal biopsy
Skin biopsy
Gastro-intestinal questionnaire
Pagi-Sym, Bristol Stool Chart, gastrointestinal symptom rating scale (GSRS)
Whole-exome sequencing
Whole-exome sequencing (WES)
Eligibility Criteria
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Inclusion Criteria
* Heterozygous or homozygous carriership of SCN5A-delPhe1617.
* Confirmed kinship to the founder population by haplotype analysis using predefined microsatellite markers.
* Written informed consent.
* Age ≥ 18 years.
* Non SCN5A-delPhe1617 genotype.
* Confirmed kinship to the Founder Group by haplotype analysis using predefined microsatellite marker.
* Written informed consent.
* Age ≥ 18 years.
* Biological parent of SCN5A-delPhe1617 positive subject participating to the Worm Study, and not belonging to study group 1 or 2.
* Written informed consent.
Exclusion Criteria
* Biological parent of SCN5A-delPhe1617 positive subject participating to the Worm Study, and not belonging to study group 1 or 2.
* Written informed consent.
18 Years
ALL
Yes
Sponsors
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Netherlands Heart Foundation
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Paul Volders, M.D., Ph.D.
Role: STUDY_DIRECTOR
Maastricht University Medical Centre
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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METC 142060
Identifier Type: -
Identifier Source: org_study_id
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