Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation (Generepol)

July 25, 2012 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

997

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Centre d'investigation clinique; Hôpital Saint Antoine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 3 hours after the taking of Sotalol
3 hours after the taking of Sotalol

Secondary Outcome Measures

Outcome 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
Time Frame: At the inclusion visit
At the inclusion visit
Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.
Time Frame: At the inclusion visit
At the inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Beny Charbit, MD, Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (ESTIMATE)

October 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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