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

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ClinicalTrials.gov Identifier: NCT00701077
Recruitment Status : Unknown
Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2008
Last Update Posted : July 4, 2008
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


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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

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

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    Key Record Dates
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