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. |
ClinicalTrials.gov Identifier: NCT00701077 |
Recruitment Status :
Terminated
(recruitments issues)
First Posted : June 19, 2008
Last Update Posted : December 7, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brugada Syndrome | Drug: 3,4-Di-amino-Pyridine Drug: placebo | Phase 3 |

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 |

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 ]

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, Learn About Clinical Studies.
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

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 | |
Paris, France, 75010 |
Principal Investigator: | Fabrice EXTRAMIANA, MD, PhD | Lariboisière University Hospital - Cardiology Department |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov 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 |
Brugada syndrome Electrophysiological study Ion channel blockade |
Brugada Syndrome Syndrome Disease Pathologic Processes Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease Genetic Diseases, Inborn |