Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Sotalol 80 mg

• Registration Number: NCT00773201
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 997

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sotalol 80 mg	Healthy subjects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre d'investigation clinique; Hôpital Saint Antoine; 🇫🇷 Paris, France