Brugada SyndromeNCT05048602
Drug-induced Brugada Syndrome Research Database
An observational study of Brugada Syndrome and Arrhythmia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brugada Syndrome, Arrhythmia, ICD
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2021to 7 Sep 2025
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with drug-induced Brudaga Syndrome
Who may be able to join
- All consecutive patients with drug-induced Brugada Syndrome
Who cannot join
- Missing Informed Consent Form
- Missing Contact Informations for Follow up
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vincenzo Russo
Naples, Napoli, 80131
Vincenzo Russo, vincenzo.russo@unicampania.it
About this study
All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.
- Conditions
- Brugada Syndrome, Arrhythmia, ICD
- Medical subject headings
- Brugada Syndrome, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden Cardiac Death
Unexpected death due to cardiac causes that occurs in a short time period.
Measured: 1 year
Appropriate ICD Therapies
Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Sep 2021
- Primary completion7 Sep 2023 (estimated)
- Study completion7 Sep 2025 (estimated)
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Russo, University of Campania Luigi Vanvitelli
- Investigators
- Vincenzo Russo, MD PhD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048602
- Sponsor's protocol ID
- 07082021
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-induced Brugada Syndrome Research Database
- ClinicalTrials.gov ID
- NCT05048602
- Acronym / sponsor ID
- 07082021
- Conditions
- Brugada Syndrome, Arrhythmia, ICD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 7 Sep 2023 (estimated)
- Study completion
- 7 Sep 2025 (estimated)
- First posted
- 17 Sep 2021 (actual)
- 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.
All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with drug-induced Brudaga Syndrome
Key inclusion criteria (1 listed)
- All consecutive patients with drug-induced Brugada Syndrome
Key exclusion criteria (2 listed)
- Missing Informed Consent Form
- Missing Contact Informations for Follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sudden Cardiac Death
Time frame: 1 year
Unexpected death due to cardiac causes that occurs in a short time period.
Appropriate ICD Therapies
Time frame: 1 year
Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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.
Vincenzo Russo, MD PhD study chair
University of Campania Luigi Vanvitelli
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 Arrhythmia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Russo, MD PhD (+390817062355, vincenzo.russo@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Cardiac Death (time frame: 1 year). The study lists 2 primary outcomes in all. 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 17 Sep 2021.