Trial record 3 of 6 for:
"Brugada syndrome"
Empiric Quinidine for Asymptomatic Brugada Syndrome
This study is currently recruiting participants.
Verified September 2012 by International Registry of Asymptomatic Brugada Syndrome
Sponsor:
International Registry of Asymptomatic Brugada Syndrome
Information provided by (Responsible Party):
Dr. Sami Viskin, International Registry of Asymptomatic Brugada Syndrome
ClinicalTrials.gov Identifier:
NCT00789165
First received: November 8, 2008
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to determine if quinidine therapy (not guided by the results of electrophysiologic studies) will reduce the long-term risk of arrhythmic events in asymptomatic Brugada Syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Arrhythmia |
Drug: quinidine Drug: no therapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Brugada syndrome
MedlinePlus related topics:
Arrhythmia
U.S. FDA Resources
Further study details as provided by International Registry of Asymptomatic Brugada Syndrome:
Primary Outcome Measures:
- Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias. [ Time Frame: Long term (>5 years) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Quinidine
Patients with type I Brugada electrocardiogram (either spontaneous or following a drug challenge with sodium channel blocker) who never experienced arrhythmia-related symptoms. Patients will receive quinidine therapy at the discretion of the attending physician.
|
Drug: quinidine
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Other Names:
|
|
Active Comparator: no therapy
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
|
Drug: quinidine
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Other Names:
Drug: no therapy
No therapy; this is not a placebo-controlled trial
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with Asymptomatic Brugada syndrome.
- "Brugada syndrome" is defined as the presence of a Type-I Brugada electrocardiogram [coved ST-segment elevation ≥2 mm (0.2 mV) in V1, V2 or V3] either spontaneously (at rest, in the baseline state or during a febrile episode) or following a standard drug-challenge test (with flecainide, ajmaline, procainamide, or pilsicainide) and recorded either with standard electrode position or with the precordial electrodes placed on the second or third intercostal space. Negative T waves in the precordial leads are not required to define a Type I electrocardiogram.
- "Asymptomatic patients" will be defined as patients without a history of cardiac arrest, a history of "arrhythmic syncope" or a history of "suspected arrhythmic syncope." Arrhythmic syncope" is a syncope occurring during documented ventricular tachyarrhythmias. "Suspected arrhythmic syncope" is syncope without documented arrhythmias believed to be caused by a tachyarrhythmia based on clinical judgment. In other words, patients with typical vagal syncope will be counted as "asymptomatic" and will be accepted to the registry whereas patients with a clinical history suggesting "syncope other than vagal syncope" will not be accepted to this Registry.
- Genetic confirmation (identification of a disease-causing mutation) will not be required for establishing the diagnosis of Brugada syndrome but will be recorded when present.
Patients with Questionable Brugada Syndrome who are asymptomatic.
- Patients with "Questionable Brugada Syndrome" are defined as patients with type II or III electrocardiogram who have an inconclusive result during a drug challenge with a sodium channel blocker. "Asymptomatic" is defined as above.
- Genetic testing will not be required. However, patients with "Questionable Brugada" based on electrocardiographic criteria will be defined as "Patients with Brugada Syndrome" if a disease-causing mutation is identified.
Exclusion Criteria:
- A history of cardiac arrest, "arrhythmic syncope" or "suspected arrhythmic syncope" (as defined above).
- Evidence of organic heart disease. The evaluation considered mandatory for excluding heart disease will consist of electrocardiogram, echocardiogram and exercise stress testing. Additional tests will be performed only if clinically indicated.
- Evidence of non-cardiac disease likely to affect 5-year survival.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789165
Contacts
| Contact: Sami Viskin, M.D. | 97236973311 | saviskin@tasmc.health.gov.il |
Locations
| United States, New York | |
| Masonic Medical Research Laboratory | Not yet recruiting |
| Utica, New York, United States, 13501-1787 | |
| Contact: Charles Antzelevitch, PhD, FACC, FAHA, FHRS (315) 735-2217 ext 117 ca@mmrl.edu | |
| Principal Investigator: Charles Antzelevitch, PhD, FACC, FAHA, FHRS | |
| Germany | |
| University Medical Centre Mannheim | Recruiting |
| Mannheim, Germany | |
| Contact: Boris Rudic, MD boris.rudic@umm.de | |
| Principal Investigator: Boris Rudic, MD | |
| Israel | |
| Tel Aviv Medical Center | Recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Sami Viskin, M.D. 972524266859 saviskin@tasmc.health.gov.il | |
| Sub-Investigator: Bernard Belhassen, M.D. | |
| Italy | |
| University of Pavia and IRCCS Fondazione Policlinico San Matteo | Recruiting |
| Pavia, Italy | |
| Contact: Lia Crotti, MD PhD l.crotti@smatteo.pv.it | |
| Sub-Investigator: Lia Crotti, MD PhD | |
| Principal Investigator: Peter J Schwartz, MD | |
| Japan | |
| National Cardiovascular Center | Recruiting |
| Osaka, Japan | |
| Contact: Wataru Shimizu, M.D. :wshimizu@hsp.ncvc.go.jp | |
| Principal Investigator: Wataru Shimizu, M.D. | |
| Netherlands | |
| Academic Medical Centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Arthur AM Wilde, M.D. a.a.wilde@amc.uva.nl | |
| Sub-Investigator: Hanno L. Tan, M.D. PhD | |
| Principal Investigator: Arthur AM Wilde, MD PhD | |
Sponsors and Collaborators
International Registry of Asymptomatic Brugada Syndrome
Investigators
| Principal Investigator: | Sami Viskin, M.D. | Tel Aviv Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Sami Viskin, International RABS director, International Registry of Asymptomatic Brugada Syndrome |
| ClinicalTrials.gov Identifier: | NCT00789165 History of Changes |
| Other Study ID Numbers: | 1297368, No grants at this point |
| Study First Received: | November 8, 2008 |
| Last Updated: | September 28, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by International Registry of Asymptomatic Brugada Syndrome:
|
Brugada syndrome quinidine Asymptomatic Brugada Syndrome |
Additional relevant MeSH terms:
|
Brugada Syndrome Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Genetic Diseases, Inborn Quinidine Quinidine gluconate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013