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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Brugada Syndrome	Drug: 3,4-Di-amino-Pyridine; Drug: placebo	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome
Study Start Date :	July 2008
Estimated Primary Completion Date :	July 2013
Estimated Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 3,4-Di-amino-Pyridine : a single 20 mg dosing	Drug: 3,4-Di-amino-Pyridine; a single 20 mg dosing
Placebo Comparator: 2	Drug: placebo; placebo

Outcome Measures

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Primary Outcome Measures :

1. Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake [ Time Frame: 45 minutes after drug intake ]

Secondary Outcome Measures :

1. the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes) [ Time Frame: at 45 minutes ]
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Lariboisière University Hospital - Cardiology department	Not yet recruiting
Paris, France, 75010
Contact: Fabrice EXTRAMIANA, MD, PhD 33-014-995 ext 8674 fabrice.extramiana@lrb.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Fabrice EXTRAMIANA, MD, PhD	Lariboisière University Hospital - Cardiology Department

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Isabelle BRINDEL, Department Clinical Research of developpement
ClinicalTrials.gov Identifier:	NCT00701077 History of Changes
Other Study ID Numbers:	P060802; EUDRACT 2007-004133-42
First Posted:	June 19, 2008
Last Update Posted:	July 4, 2008
Last Verified:	June 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Brugada syndrome; Electrophysiological study; Ion channel blockade

Additional relevant MeSH terms:

Brugada Syndrome; Syndrome; Disease; Pathologic Processes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases	Genetic Diseases, Inborn; 3,4-diaminopyridine; 4-Aminopyridine; Potassium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action