DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is implanted to prevent sudden cardiac death. ICD are however associated with potential complications and are not available in all countries.Pharmacological blockade of specific ion channels (Ito) represents a promising therapeutic approach in this syndrome.The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.The aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility in Brugada patients requiring an electrophysiological study for arrhythmic risk stratification.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: 3,4-diaminopyridine; 4-Aminopyridine

Criteria

Inclusion Criteria:

• Man or woman ≥ 18 years old

• Brugada syndrome diagnosed with a type 1 ECG either spontaneous or drug-induced

• Electrophysiological study indicated for arrhythmic risk stratification purpose

• Inducibility of a sustained ventricular tachycardia (> 30 seconds) or ventricular fibrillation requiring defibrillation

• Physical medical examination

• Signed written informed consent

Exclusion Criteria:

• Personal or familial history of epilepsy

• Pregnancy

• Body weight > 100 kg

• the need of >1 counter shock for defibrillation

• Alcohol or cocaine consumption during the protocol

• Class I (with the exception of local anaesthesia by lidocaine), II, III and IV antiarrhythmic drugs, antidepressant drugs, ATP dependent potassium channel activators, sultopride not stopped for > 7 halve-lives

• No medical insurance