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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524079
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Study Description
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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
Brugada Syndrome 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
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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 : April 19, 2018
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : November 9, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524079


Locations
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Italy
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Carlo Pappone, MD IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
 Genetic Diseases, Inborn
Ajmaline
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action