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Trial record 1 of 6 for:    "Brugada syndrome"
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DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome (DAPREB)

This study is not yet open for participant recruitment.
Verified June 2008 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00701077
First received: June 18, 2008
Last updated: July 1, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome

Resource links provided by NLM:

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 ] [ 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
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

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 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

No publications provided

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
Study First Received: June 18, 2008
Last Updated: July 1, 2008
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Brugada syndrome
Electrophysiological study
Ion channel blockade

Additional relevant MeSH terms:
Brugada Syndrome
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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013