Right Ventricle Morphology and Hemodynamics in BrS

Brugada Syndrome Clinical Trial

— RV-BrS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524079
• Other study ID #: RV & BrS
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: November 9, 2019

Study information

• Verified date: May 2021
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 9, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Electrical substrate changes of the right ventricle	electroanatomical epicardial mapping for substrate determination before and after ajmaline	1 day after ICD implantation