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Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Sotalol 80 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Beny Charbit, MD, Principal Investigator, Affiliation: H├┤pital Saint Antoine, Assistance Publique - Hopitaux de Paris

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

Clinical Details

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

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

Primary outcome: The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol.

Secondary outcome:

Constitute a biological base and a phenotypic base of resources which will allow to define answer phenotypes to the implemented dynamic tests

Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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 ┬▓

- 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

Locations and Contacts

Centre d'investigation clinique; H├┤pital Saint Antoine, Paris 75012, France
Additional Information

Starting date: February 2008
Last updated: July 25, 2012

Page last updated: August 23, 2015

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