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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 : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

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 suspected BrS-ECG pattern will perform an ajmaline testing (1mg/kg in 5 min). A total of 30 patients with positive testing and 30 patients with negative testing will be selected and enrolled. Patients will perform cardiac magnetic resonance and 3D echocardiography imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. Patients with positive testing will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.

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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


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)




Primary Outcome Measures :
  1. echocardiographic parameters changes of the right and left ventricle function [ Time Frame: 1 day during Echocardiography ]
    Changes of right ejection fraction 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. echocardiographic parameters changes of the right and left ventricle function [ Time Frame: 1 day during Echocardiography ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 60 selected subjects (30 patients with positive ajmaline testing and 30 with negative testing) will be enrolled.
Criteria

Inclusion Criteria:

  • Suspicious Brugada syndrome
  • 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

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
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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: March 27, 2020
Last Verified: March 2020
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