DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome (DAPREB)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brugada Syndrome | Drug: 3,4-Di-amino-Pyridine Drug: placebo | Phase 3 |

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 |

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
|
- Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake [ Time Frame: 45 minutes after drug intake ]
- the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes) [ Time Frame: at 45 minutes ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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
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 |
Principal Investigator: | Fabrice EXTRAMIANA, MD, PhD | Lariboisière University Hospital - Cardiology Department |
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 |
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:
Brugada Syndrome 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 |