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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. Identifier: NCT00701077
Recruitment Status : Terminated (recruitments issues)
First Posted : June 19, 2008
Last Update Posted : December 7, 2020
Information provided by (Responsible Party):
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)
Actual Enrollment : 5 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
Actual Study Start Date : September 12, 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

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

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

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 identifier (NCT number): NCT00701077

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Lariboisière University Hospital - Cardiology department
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Fabrice EXTRAMIANA, MD, PhD Lariboisière University Hospital - Cardiology Department
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00701077    
Other Study ID Numbers: P060802
EUDRACT 2007-004133-42
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
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
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn