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RV-BrS: Right Ventricle Morphology and Hemodynamics in BrS

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Completed
CT.gov ID
NCT03524079
Collaborator
(none)
60
Enrollment
1
Location
18.7
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
Actual Study Start Date :
Apr 19, 2018
Actual Primary Completion Date :
Nov 8, 2019
Actual Study Completion Date :
Nov 9, 2019

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. Electrical substrate changes of the right ventricle [1 day after ICD implantation]

    electroanatomical epicardial mapping for substrate determination before and after ajmaline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Policlinico S. Donato San Donato Milanese Milano Italy 20097

Sponsors and Collaborators

  • IRCCS Policlinico S. Donato

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carlo Pappone, Head of Arrhythmology Department, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT03524079
Other Study ID Numbers:
  • RV & BrS
First Posted:
May 14, 2018
Last Update Posted:
May 18, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Brugada Syndrome
Syndrome
Ajmaline

Study Results

No Results Posted as of May 18, 2021