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

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00701077

Purpose

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	Intervention	Phase
Brugada Syndrome	Drug: 3,4-Di-amino-Pyridine Drug: placebo	Phase III

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

Drug Information available for: 3,4-Diaminopyridine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake [ Time Frame: 45 minutes after drug intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes) [ Time Frame: at 45 minutes ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3,4-Di-amino-Pyridine : a single 20 mg dosing	Drug: 3,4-Di-amino-Pyridine a single 20 mg dosing
2: Placebo Comparator	Drug: placebo placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701077

Locations

France
Lariboisière University Hospital - Cardiology department
Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Fabrice EXTRAMIANA, MD, PhD

Lariboisière University Hospital - Cardiology Department

More Information

No publications provided

Responsible Party:	Department Clinical Research of developpement ( Isabelle BRINDEL )
Study ID Numbers:	P060802, EUDRACT 2007-004133-42
Study First Received:	June 18, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00701077 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Brugada syndrome
Electrophysiological study
Ion channel blockade

Study placed in the following topic categories:

Heart Diseases
Genetic Diseases, Inborn
Brugada Syndrome
Potassium Channel Blockers

3,4-diaminopyridine
Cardiovascular Agents
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Heart Diseases
Molecular Mechanisms of Pharmacological Action
3,4-diaminopyridine
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes

Genetic Diseases, Inborn
Therapeutic Uses
Syndrome
Brugada Syndrome
Potassium Channel Blockers
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009