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
Overview
- Phase
- Phase 1
- Intervention
- Sotalol 80 mg
- Conditions
- Healthy Volunteers
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 997
- Locations
- 1
- Primary Endpoint
- The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
1
Healthy subjects
Intervention: Sotalol 80 mg
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.(At the inclusion visit)
- 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)