Back to resultsAssessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study (BARODEF)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Baroreflex assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Patients implanted with an implantable cardioverter defibrillator for primary prevention of of cardiac sudden death, ischaemic cardiomyopathy
- Implantable cardioverter defibrillators implantation for at least 3 years
- Age ≥ 18 years
Exclusion Criteria:
- ventricular or atrial pacing ≥1%,
- atrial fibrillation history
- age under 18 years
Sites / Locations
- CHU DE Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BAROREFLEX
Arm Description
Outcomes
Primary Outcome Measures
spontaneous baroreflex sensitivity by the sequence method (mean slope)
Secondary Outcome Measures
Full Information
NCT ID
NCT02930382
First Posted
October 10, 2016
Last Updated
August 6, 2018
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02930382
Brief Title
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
Acronym
BARODEF
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
May 26, 2016 (Actual)
Study Completion Date
May 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief Summary
We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention.
Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden cardiac death after MI.
Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after MI was predictor of sudden death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAROREFLEX
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Baroreflex assessment
Primary Outcome Measure Information:
Title
spontaneous baroreflex sensitivity by the sequence method (mean slope)
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients implanted with an implantable cardioverter defibrillator for primary prevention of of cardiac sudden death, ischaemic cardiomyopathy
Implantable cardioverter defibrillators implantation for at least 3 years
Age ≥ 18 years
Exclusion Criteria:
ventricular or atrial pacing ≥1%,
atrial fibrillation history
age under 18 years
Facility Information:
Facility Name
CHU DE Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
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