Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Study Primary Completion Date: December 2010

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.

Intervention(s) in this Clinical Trial

• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Healthy subjects

Primary Measures

• The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol.
  • Time Frame: 3 hours after the taking of Sotalol
    Safety Issue?: No

Secondary Measures

• Constitute a biological base and a phenotypic base of resources which will allow to define answer phenotypes to the implemented dynamic tests
  • Time Frame: At the inclusion visit
    Safety Issue?: No
• Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.
  • Time Frame: At the inclusion visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Beny Charbit, MD Principal Investigator Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris  

Overall Contact: Beny Charbit, MD +33 (0) 1 49 28 24 04 beny.charbit@sat.aphp.fr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00773201

Study ID Number: P071001

ClinicalTrials.gov Identifier: NCT00773201

Health Authority: France: Afssaps - French Health Products Safety Agency