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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00701077

First Posted: June 19, 2008

Last Update Posted: July 4, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Assistance Publique - Hôpitaux de Paris

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 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome

Genetic and Rare Diseases Information Center resources: Brugada Syndrome

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]


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
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

Show Detailed Description

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701077

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


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 Submitted:	June 18, 2008
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:


Syndrome Brugada 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

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