Right Ventricle Morphology and Hemodynamics in BrS
RV-BrS
Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedStudy Start
First participant enrolled
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2019
CompletedMay 18, 2021
May 1, 2021
1.6 years
April 19, 2018
May 16, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Electrocardiographic changes
Changes of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
1 day during Electrocardiography
MRI changes of left and right ventricular function
MRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
1day during MRI
CMR parameters changes of the right and left ventricle function
Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
1 day during CMR
Electrical substrate changes of the right ventricle
electroanatomical epicardial mapping for substrate determination before and after ajmaline
1 day after ICD implantation
Study Arms (2)
BrS Group
Ajmaline 17-(Chloroacetate) Monohydrochloride
No BrS group
Ajmaline 17-(Chloroacetate) Monohydrochloride
Interventions
Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)
Eligibility Criteria
A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Contraindication to CMRI or to ajmaline
- Live espectance \< 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097, Italy
Related Publications (1)
Pappone C, Santinelli V, Mecarocci V, Tondi L, Ciconte G, Manguso F, Sturla F, Vicedomini G, Micaglio E, Anastasia L, Pica S, Camporeale A, Lombardi M. Brugada Syndrome: New Insights From Cardiac Magnetic Resonance and Electroanatomical Imaging. Circ Arrhythm Electrophysiol. 2021 Nov;14(11):e010004. doi: 10.1161/CIRCEP.121.010004. Epub 2021 Oct 25.
PMID: 34693720DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Pappone, MD
IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Arrhythmology Department
Study Record Dates
First Submitted
April 19, 2018
First Posted
May 14, 2018
Study Start
April 19, 2018
Primary Completion
November 8, 2019
Study Completion
November 9, 2019
Last Updated
May 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share