Clinical Trials Directory

Trials / Completed

CompletedNCT03524079

Right Ventricle Morphology and Hemodynamics in BrS

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
IRCCS Policlinico S. Donato · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAjmaline 17-(Chloroacetate) MonohydrochlorideAjmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

Timeline

Start date
2018-04-19
Primary completion
2019-11-08
Completion
2019-11-09
First posted
2018-05-14
Last updated
2021-05-18

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03524079. Inclusion in this directory is not an endorsement.