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Completed

NCT Number: NCT00773201

Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

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

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Key information

Conditions

Healthy Volunteers Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Long QT Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre d'investigation clinique; Hôpital Saint Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sotalol 80 mg

Drug

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

Primary outcomes

  1. 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

  1. 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

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

    Time frame: At the inclusion visit

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Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: Generepol

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2008
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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