Brugada SyndromeNCT02302274
Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
An observational study of Brugada Syndrome and Arrhythmogenic Right Ventricular Cardiomyopathy, run by NYU Langone Health at 1 site in United States.
Trial summary
The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the USA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brugada Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy
- What is being tested?
- flecainide iv
- Type of treatment
- Injection or infusion
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 26 Jul 2017
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients (age>18) who are seen in the Cardiovascular Genetics Program with a suspect diagnosis of Brugada Syndrome or with a suspect diagnosis of ARVC. This study will enroll adult individuals who are referred to the Center with a suspect of Brugada Syndrome or ARVC on the basis of uncertain ECG pattern, family history for sudden death syncope and/or cardiac arrest and/or ventricular arrhythmia in the absence of clear clinical markers for any other inherited cardiac disease.
Who may be able to join
- Suspect diagnosis of Brugada Syndrome or ARVC
- Idiopathic ventricular fibrillation and suspect concealed Brugada syndrome
- Family history of Brugada Syndrome
- Family history of unexpected cardiac sudden death
Who cannot join
- Type 1 Brugada Syndrome ECG
- Pregnancy
- History and/or evidence of ischemic cardiomyopathy
- Recent myocardial infarction
- Allergy or known adverse reaction to flecainide
Trial locations and contacts
1 site in 1 country.
United States1 site
New york University, School of Medicine
New York, New York, 10010
About this study
The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.
Read the detailed description
Brugada Syndrome is an inherited arrhythmogenic disease responsible for life-threatening arrhythmias and sudden cardiac death in young individuals with structural normal heart.
It is characterized by a peculiar ECG pattern, but this pattern could be intermittent. The infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a concealed ECG pattern, thus providing an essential contribution to the diagnosis of this condition.
In the current clinical practice in USA, only procainamide is used for diagnostic purposes; however in Europe only ajmaline and flecainide, available as iv formulations, are widely used. European and Japanese studies have demonstrated that the use of flecainide harbors less risks of adverse events in patients and may have a higher accuracy in unraveling the presence of the disease.
In the present study the investigators propose to use flecainide infusion test in the Cardiovascular Genetics Program at NYUMC, in order to assess its sensitivity and specificity in diagnosing the disease and compare the incidence of adverse events to that observed during procainamide use.
Additionally, the investigators propose to extend the study protocol to patients with a suspect diagnosis of Arrhythmogenic Right Ventricular Tachycardia (ARVC), due to the possible overlap between the two conditions.
The study has the following aims:
- To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared to procainamide infusion for the diagnosis of Brugada Syndrome.
- To demonstrate that flecainide is equally safe or safer than procainamide to use for diagnosing Brugada Syndrome.
- To demonstrate that flecainide has high sensitivity and specificity in diagnosing also some patients with early stage Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).
- Being tested
- flecainide iv
- Keywords
- Brugada Syndrome, ARVC, flecainide, ST elevation
- Medical subject headings
- Brugada Syndrome, Arrhythmogenic Right Ventricular Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flecainide ivDrug
infusion over 10 min
| Study group | Role | What they receive |
|---|---|---|
| flecainide infusion test | Patients with suspect Brugada Syndrome will be asked to undergo flecainide infusion (2 mg/Kg up to 150 mg maximum dose) over 10 minutes and their ECG will be continuously monitored. The objective of the study is to investigate if they show conversion from type 2 or type 3 ECG to a diagnostic type 1 ECG. Receives: Drug: flecainide iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis
conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG
Measured: 10 minutes
Secondary outcomes (1)
absence of arrhythmias elicited during the test
number of arrhythmias caused by
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study start1 Jul 2010
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Fowler, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302274
- Sponsor's protocol ID
- 10-00253
- Status last verified
- Apr 2019
- First submitted
- 24 Nov 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
- ClinicalTrials.gov ID
- NCT02302274
- Acronym / sponsor ID
- 10-00253
- Keywords
- Brugada Syndrome, ARVC, flecainide, ST elevation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2010
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 26 Nov 2014 (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 study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients and its higher sensitivity when compared to procainamide infusion (the conventional drug used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.
Detailed description
Brugada Syndrome is an inherited arrhythmogenic disease responsible for life-threatening arrhythmias and sudden cardiac death in young individuals with structural normal heart.
It is characterized by a peculiar ECG pattern, but this pattern could be intermittent. The infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a concealed ECG pattern, thus providing an essential contribution to the diagnosis of this condition.
In the current clinical practice in USA, only procainamide is used for diagnostic purposes; however in Europe only ajmaline and flecainide, available as iv formulations, are widely used. European and Japanese studies have demonstrated that the use of flecainide harbors less risks of adverse events in patients and may have a higher accuracy in unraveling the presence of the disease.
In the present study the investigators propose to use flecainide infusion test in the Cardiovascular Genetics Program at NYUMC, in order to assess its sensitivity and specificity in diagnosing the disease and compare the incidence of adverse events to that observed during procainamide use.
Additionally, the investigators propose to extend the study protocol to patients with a suspect diagnosis of Arrhythmogenic Right Ventricular Tachycardia (ARVC), due to the possible overlap between the two conditions.
The study has the following aims:
- To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared to procainamide infusion for the diagnosis of Brugada Syndrome.
- To demonstrate that flecainide is equally safe or safer than procainamide to use for diagnosing Brugada Syndrome.
- To demonstrate that flecainide has high sensitivity and specificity in diagnosing also some patients with early stage Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flecainide infusion test | – | Drug: flecainide ivPatients with suspect Brugada Syndrome will be asked to undergo flecainide infusion (2 mg/Kg up to 150 mg maximum dose) over 10 minutes and their ECG will be continuously monitored. The objective of the study is to investigate if they show conversion from type 2 or type 3 ECG to a diagnostic type 1 ECG. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (age>18) who are seen in the Cardiovascular Genetics Program with a suspect diagnosis of Brugada Syndrome or with a suspect diagnosis of ARVC. This study will enroll adult individuals who are referred to the Center with a suspect of Brugada Syndrome or ARVC on the basis of uncertain ECG pattern, family history for sudden death syncope and/or cardiac arrest and/or ventricular arrhythmia in the absence of clear clinical markers for any other inherited cardiac disease.
Key inclusion criteria (4 listed)
- Suspect diagnosis of Brugada Syndrome or ARVC
- Idiopathic ventricular fibrillation and suspect concealed Brugada syndrome
- Family history of Brugada Syndrome
- Family history of unexpected cardiac sudden death
Key exclusion criteria (5 listed)
- Type 1 Brugada Syndrome ECG
- Pregnancy
- History and/or evidence of ischemic cardiomyopathy
- Recent myocardial infarction
- Allergy or known adverse reaction to flecainide
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 |
|---|---|---|
| flecainide ivinfusion over 10 min | Drug | flecainide infusion test |
Primary outcome
diagnosis
Time frame: 10 minutes
conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG
1 secondary outcome
absence of arrhythmias elicited during the test
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Related trials for Brugada Syndrome
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
RecruitingObservational study
Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome
Brugada Syndrome (BrS), Ventricular Arrhythmia
RecruitingObservational study
Sudden Unexplained Death in Childhood (SUDC) Registry
Sudden Unexplained Death Syndrome, Sudden Unexplained Death in Childhood
RecruitingObservational study
Distribution of Cell-cell Junction Proteins in Arrhythmic Disorders
Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome
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.
Steven Fowler, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome and Arrhythmogenic Right Ventricular Cardiomyopathy, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnosis (time frame: 10 minutes). 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 18 Apr 2019.