Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773201

Acronym

Generepol

Enrollment

997

Registered

2008-10-16

Start date

2008-02-29

Completion date

2012-03-31

Last updated

2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Long QT syndrome, Cardiac repolarisation, Genome-wide association, Electrophysiology, Drugs/adverse effects

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.

Interventions

DRUGSotalol 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026