Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00773201

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Sotalol 80 mg	Phase I

Genetics Home Reference related topics: Andersen-Tawil syndrome Jervell and Lange-Nielsen syndrome Romano-Ward syndrome

Drug Information available for: Sotalol Sotalol hydrochloride

U.S. FDA Resources

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms. [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Healthy subjects	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773201

Contacts

Contact: Beny Charbit, MD

+33 (0) 1 49 28 24 04

beny.charbit@sat.aphp.fr

Locations

France
Centre d'investigation clinique; Hôpital Saint Antoine	Recruiting
Paris, France, 75012
Contact: Beny Charbit, MD +33 (0) 1 49 28 24 04 beny.charbit@sat.aphp.fr
Principal Investigator: Beny Charbit, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Beny Charbit, MD

Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Yannick Vacher )
Study ID Numbers:	P071001, AOM, EUD2007-005780-99, ENRA70939-37
Study First Received:	October 15, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00773201
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Long QT syndrome
Cardiac repolarisation
Genome-wide association

Electrophysiology
Drugs/adverse effects
Healthy volunteers

Study placed in the following topic categories:

Long QT Syndrome
Healthy
Sotalol

Additional relevant MeSH terms:

Neurotransmitter Agents
Sympatholytics
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions

Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009