DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome (DAPREB)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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:
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701077
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
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 29, 2016