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

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.
 
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

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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

Resource links provided by the National Library of Medicine


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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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France
Lariboisière University Hospital - Cardiology department
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
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Principal Investigator: Fabrice EXTRAMIANA, MD, PhD Lariboisière University Hospital - Cardiology Department

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Responsible Party: Isabelle BRINDEL, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00701077    
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:
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Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn
Amifampridine
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action