Right Ventricle Morphology and Hemodynamics in BrS

Completed

• Conditions: Brugada Syndrome
• Interventions: Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

• Registration Number: NCT03524079
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-14
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BrS Group	Ajmaline 17-(Chloroacetate) Monohydrochloride	Ajmaline 17-(Chloroacetate) Monohydrochloride
No BrS group	Ajmaline 17-(Chloroacetate) Monohydrochloride	Ajmaline 17-(Chloroacetate) Monohydrochloride

Primary Outcome Measures

Name	Time	Method
Electrocardiographic changes	1 day during Electrocardiography	Changes 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 function	1day during MRI	MRI 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 function	1 day during CMR	Changes of right ventricular areal strain before and after ajmaline in Brugada patients as compared with controls
Electrical substrate changes of the right ventricle	1 day after ICD implantation	electroanatomical epicardial mapping for substrate determination before and after ajmaline

Trial Locations

Locations (1)

IRCCS Policlinico S. Donato; 🇮🇹 San Donato Milanese, Milano, Italy