Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation
NCT ID: NCT00773201
Last Updated: 2012-07-26
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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COMPLETED
PHASE1
997 participants
INTERVENTIONAL
2008-02-29
2012-03-31
Brief Summary
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The phenotypic characterization, based on the ventricular repolarisation dynamics will be used aiming at term of the predictive genetic factors of the acquired long QT syndrome
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Healthy subjects
Sotalol 80 mg
healthy subjects will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA
Interventions
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Sotalol 80 mg
healthy subjects will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 60 years
* European or North African Origin
* Body mass index between 19 and 29 kg / m ²
* Obtaining informed and written consent
Exclusion Criteria
* Heart rate \< 50 bpm
* Systolic blood pressure \< 100 mm Hg
* Atrioventricular block
* Known chronic illness with chronic treatment
* Raynaud phenomenon
* QT prolonging drug
* Family or personal history of the congenital long QT syndrome
* QT/QTc Fridericia (QTcf) \> 450 ms
* Pregnancy
18 Years
60 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Beny Charbit, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris
Locations
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Centre d'investigation clinique; Hôpital Saint Antoine
Paris, , France
Countries
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References
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Salem JE, Germain M, Hulot JS, Voiriot P, Lebourgeois B, Waldura J, Tregouet DA, Charbit B, Funck-Brentano C. GENomE wide analysis of sotalol-induced IKr inhibition during ventricular REPOLarization, "GENEREPOL study": Lack of common variants with large effect sizes. PLoS One. 2017 Aug 11;12(8):e0181875. doi: 10.1371/journal.pone.0181875. eCollection 2017.
Other Identifiers
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P071001
Identifier Type: -
Identifier Source: org_study_id