Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Study Overview
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Brief Summary
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The main objective is to research for genetic factors involved in the extreme modifications of the QT interval of the electrocardiogram in answer to a pharmacological stimulation (sotalol) and physiological stimulation in the apparently normal general population. 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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Study of 1000 apparently healthy subjects which will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA.

Official Title
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Identification of the Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation at a Pharmacological and Physiological Stimulus in an Apparently Normal Population

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Sotalol 80 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes 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: Asthma 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy subjects | Drug: Sotalol 80 mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol. |  | 3 hours after the taking of Sotalol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constitute a biological base and a phenotypic base of resources which will allow to define answer phenotypes to the implemented dynamic tests |  | At the inclusion visit | 
| Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms. |  | At the inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long QT syndrome, Cardiac repolarisation, Genome-wide association, Electrophysiology, Drugs/adverse effects