Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

NCT00773201 | Completed Phase 1

• 1 other identifier: P071001
• Study Type: interventional
• Target: 997
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Keywords

Long QT syndrome; Cardiac repolarisation; Genome-wide association; Electrophysiology; Drugs/adverse effects

Outcome Measures

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.

  3 hours after the taking of Sotalol

Secondary Outcomes (2)

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

  At the inclusion visit

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

  At the inclusion visit

Study Arms (1)

1

EXPERIMENTAL

Healthy subjects

Drug: Sotalol 80 mg

Interventions

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

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre d'investigation clinique; Hôpital Saint Antoine

Paris, 75012, France

Location

Related Publications (1)

• Salem JE, Germain M, Hulot JS, Voiriot P, Lebourgeois B, Waldura J, Tregouet DA, Charbit B, Funck-Brentano C. GENomE wide analysis of sotalol-induced IKr inhibition during ventricular REPOLarization, "GENEREPOL study": Lack of common variants with large effect sizes. PLoS One. 2017 Aug 11;12(8):e0181875. doi: 10.1371/journal.pone.0181875. eCollection 2017.

  PMID: 28800628 DERIVED

MeSH Terms

Conditions

Long QT Syndrome

Interventions

Sotalol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Beny Charbit, MD

  Hôpital Saint Antoine, Assistance Publique - Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 26, 2012

Record last verified: 2012-06

Locations

FR (1)