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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773201
First Posted: October 16, 2008
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
October 15, 2008
October 16, 2008
July 26, 2012
February 2008
March 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00773201 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms. [ Time Frame: At the inclusion visit ]
Same as current
Not Provided
Not Provided
 
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

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 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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
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
Experimental: 1
Healthy subjects
Intervention: Drug: Sotalol 80 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
997
March 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00773201
P071001
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Beny Charbit, MD Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP