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

NCT00701077 | Terminated Phase 3

• 2 other identifiers: P060802EUDRACT 2007-004133-42
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brugada Syndrome

Keywords

Brugada syndrome; Electrophysiological study; Ion channel blockade

Outcome Measures

Primary Outcomes (1)

• Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake

  45 minutes after drug intake

Secondary Outcomes (2)

• the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes)

  at 45 minutes

• the relationship between 3,4-DAP plasma concentration measured at 45 minutes and electrophysiological study result and ST segment elevation

  at 45 minutes

Study Arms (2)

1

EXPERIMENTAL

3,4-Di-amino-Pyridine : a single 20 mg dosing

Drug: 3,4-Di-amino-Pyridine

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

3,4-Di-amino-Pyridine DRUG

a single 20 mg dosing

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Lariboisière University Hospital - Cardiology department

Paris, 75010, France

Location

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fabrice EXTRAMIANA, MD, PhD

  Lariboisière University Hospital - Cardiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: September 12, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

FR (1)