Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Healthy Volunteers Clinical Trial

— Generepol  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773201
• Other study ID #: P071001
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: July 25, 2012
• Start date: February 2008
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Centre d'investigation clinique; Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.		At the inclusion visit	No