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

S

San Donato Group (GSD)

Status

Completed

Conditions

Brugada Syndrome

Treatments

Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

Study type

Observational

Funder types

Other

Identifiers

NCT03524079
RV & BrS

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

BrS Group
Description:
Ajmaline 17-(Chloroacetate) Monohydrochloride
Treatment:
Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
No BrS group
Description:
Ajmaline 17-(Chloroacetate) Monohydrochloride
Treatment:
Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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