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Right Ventricle Morphology and Hemodynamics in BrS

Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03524079
Acronym
RV-BrS
Enrollment
60
Registered
2018-05-14
Start date
2018-04-19
Completion date
2019-11-09
Last updated
2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brugada Syndrome

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.

Detailed description

All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.

Interventions

DRUGAjmaline 17-(Chloroacetate) Monohydrochloride

Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Electrocardiographic changes1 day during ElectrocardiographyChanges of PR, QRS, and QT parameters, before and after ajmaline in Brugada patients as compared with control subjects
MRI changes of left and right ventricular function1day during MRIMRI changes of left and right ventricular function before and after ajmaline in Brugada patients as compared with control subjects
CMR parameters changes of the right and left ventricle function1 day during CMRChanges of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Electrical substrate changes of the right ventricle1 day after ICD implantationelectroanatomical epicardial mapping for substrate determination before and after ajmaline

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026