Right Ventricle Morphology and Hemodynamics in BrS (RV-BrS)

May 16, 2021 updated by: Carlo Pappone, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • IRCCS Policlinico S. Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BrS Group
Ajmaline 17-(Chloroacetate) Monohydrochloride
Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)
No BrS group
Ajmaline 17-(Chloroacetate) Monohydrochloride
Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiographic changes
Time Frame: 1 day during Electrocardiography
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
Time Frame: 1day during MRI
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
Time Frame: 1 day during CMR
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
Time Frame: 1 day after ICD implantation
electroanatomical epicardial mapping for substrate determination before and after ajmaline
1 day after ICD implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Investigators

  • Principal Investigator: Carlo Pappone, MD, IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

November 8, 2019

Study Completion (Actual)

November 9, 2019

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV & BrS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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