CompletedNot Applicable

Right Ventricle Morphology and Hemodynamics in BrS

Italy60 participantsStarted 2018-04-19

Plain-language summary

The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern * Indication to ajmaline testing and programmed ventricular stimulation * Age \> or equal to 18 years * Written informed consent Exclusion Criteria: * Pregnancy * Contraindication to CMRI or to ajmaline * Live espectance \< 12 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Electrocardiographic changes

Timeframe: 1 day during Electrocardiography

MRI changes of left and right ventricular function

Timeframe: 1day during MRI

CMR parameters changes of the right and left ventricle function

Timeframe: 1 day during CMR

Electrical substrate changes of the right ventricle

Timeframe: 1 day after ICD implantation

Trial details

NCT IDNCT03524079

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-08

View on ClinicalTrials.gov More Brugada Syndrome trials