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OpenTrials
Completed

NCT Number: NCT03524079

Right Ventricle Morphology and Hemodynamics in BrS

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.

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Key information

Conditions

Brugada Syndrome Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ajmaline 17-(Chloroacetate) Monohydrochloride

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Electrical substrate changes of the right ventricle

    Time frame: 1 day after ICD implantation

    electroanatomical epicardial mapping for substrate determination before and after ajmaline

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Acronym: RV-BrS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 14, 2018
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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