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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

Tracking Information
First Submitted Date April 19, 2018
First Posted Date May 14, 2018
Last Update Posted Date March 27, 2020
Actual Study Start Date April 19, 2018
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2020)
  • 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
  • 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
  • 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
  • Electrical substrate changes of the right ventricle [ Time Frame: 1 day after ICD implantation ]
    electroanatomical epicardial mapping for substrate determination before and after ajmaline
Original Primary Outcome Measures
 (submitted: May 11, 2018)
  • 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
  • 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
  • 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Right Ventricle Morphology and Hemodynamics in BrS
Official Title Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Brugada Syndrome
Intervention Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)
Study Groups/Cohorts
  • BrS Group
    Ajmaline 17-(Chloroacetate) Monohydrochloride
    Intervention: Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
  • No BrS group
    Ajmaline 17-(Chloroacetate) Monohydrochloride
    Intervention: Drug: Ajmaline 17-(Chloroacetate) Monohydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2018)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date November 9, 2019
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03524079
Other Study ID Numbers RV & BrS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Carlo Pappone, IRCCS Policlinico S. Donato
Study Sponsor IRCCS Policlinico S. Donato
Collaborators Not Provided
Investigators
Principal Investigator: Carlo Pappone, MD IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
PRS Account IRCCS Policlinico S. Donato
Verification Date March 2020