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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00773201
First received: October 15, 2008
Last updated: July 25, 2012
Last verified: June 2012
History of Changes
  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 Volunteers
 Drug: Sotalol 80 mg
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 997
Study Start Date: February 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Sotalol 80 mg

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

Locations
France
Centre d'investigation clinique; Hôpital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Beny Charbit, MD Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00773201     History of Changes
Other Study ID Numbers: P071001
Study First Received: October 15, 2008
Last Updated: July 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Sotalol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013