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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Sotalol 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00773201

P071001

Details and patient eligibility

About

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

Full 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.

Enrollment: 997 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

997 participants in 1 patient group

1

Experimental group

Description:

Healthy subjects

Treatment:

Drug: Sotalol 80 mg