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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:

Background:

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. Experimental data show that increased Ito current may be associated with both the ECG feature and arrhythmogenic substrate observed in the syndrome. Moreover, Ito blockade reverse the ECG abnormalities and suppress arrhythmogenicity.The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that is already used in humans for another indication.

Main objective:

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.

First end point:

Re-inducibility or non re-inducibility of sustained ventricular arrhythmia during electrophysiological study on treatment

Tested hypothesis:

The 3,4-DAP decreases the proportion of re-inducibility during the electrophysiological study with a re-inducibility rate of 80% in the placebo group and 25% in the 3,4-DAP group

Secondary objective:

  • to assess the effect of 3,4-DAP on ST segment elevation in Brugada patients
  • Same as current

    Current Secondary Outcome:

    • the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes) [ Time Frame: at 45 minutes ]
    • the relationship between 3,4-DAP plasma concentration measured at 45 minutes and electrophysiological study result and ST segment elevation [ Time Frame: at 45 minutes ]


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: June 18, 2008
    Date Started: July 2008
    Date Completion: July 2013
    Last Updated: July 1, 2008
    Last Verified: June 2008