Status:
COMPLETED
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 physiol...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
997 Patients enrolled
Trial Details
Trial ID
NCT00773201
Start Date
February 1 2008
End Date
March 1 2012
Last Update
July 26 2012
Active Locations (1)
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1
Centre d'investigation clinique; Hôpital Saint Antoine
Paris, France, 75012