ArrhythmiaPhase 2/3NCT00789165
Empiric Quinidine for Asymptomatic Brugada Syndrome
A Phase 2/3 study testing quinidine and no therapy in people with Arrhythmia, run by International Registry of Asymptomatic Brugada Syndrome at 6 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- quinidine and no therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Dec 2009to 31 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Italy1 site
University of Pavia and IRCCS Fondazione Policlinico San Matteo
Pavia
About this study
Official title: A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.
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.
- Conditions
- Arrhythmia
- Being tested
- quinidine, no therapy
- Keywords
- Brugada syndrome, quinidine, Asymptomatic Brugada Syndrome
- Medical subject headings
- Arrhythmias, Cardiac, Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quinidineDrug
Also called Serecor, Quiniduran
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
no therapyDrug
No therapy; this is not a placebo-controlled trial
| Study group | Role | What they receive |
|---|---|---|
| Quinidine | Experimental | 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. Receives: Drug: quinidine |
| no therapy | Active comparator | Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician Receives: Drug: quinidine; Drug: no therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.
Measured: Long term (>5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startDec 2009
- Primary completionFeb 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Registry of Asymptomatic Brugada Syndrome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sami Viskin, International Registry of Asymptomatic Brugada Syndrome
- Investigators
- Sami Viskin, M.D., Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789165
- Sponsor's protocol ID
- 1297368
- Other IDs
- No grants at this point
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2008
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.
- ClinicalTrials.gov ID
- NCT00789165
- Acronym / sponsor ID
- 1297368
- Conditions
- Arrhythmia
- Keywords
- Brugada syndrome, quinidine, Asymptomatic Brugada Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Registry of Asymptomatic Brugada SyndromeUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinidine | Experimental | Drug: quinidinePatients 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. |
| no therapy | Active comparator | Drug: quinidine, Drug: no therapyPatients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Asymptomatic Brugada syndrome.
- Patients with Questionable Brugada Syndrome who are asymptomatic.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quinidineAlso: Serecor, Quiniduranquinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily. | Drug | Quinidine, no therapy |
| no therapyNo therapy; this is not a placebo-controlled trial | Drug | no therapy |
Primary outcome
Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.
Time frame: Long term (>5 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Related trials for Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sami Viskin, M.D. principal investigator
Tel Aviv Medical Center
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing quinidine and no therapy in people with Arrhythmia, run by International Registry of Asymptomatic Brugada Syndrome at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Israel, Italy, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias. (time frame: Long term (>5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.