Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
BARODEF
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2016
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedAugust 8, 2018
August 1, 2018
Same day
October 10, 2016
August 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
spontaneous baroreflex sensitivity by the sequence method (mean slope)
10 days
Study Arms (1)
BAROREFLEX
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- ventricular or atrial pacing ≥1%,
- atrial fibrillation history
- age under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU DE Poitiers
Poitiers, 86021, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2016
First Posted
October 12, 2016
Study Start
May 26, 2016
Primary Completion
May 26, 2016
Study Completion
May 26, 2016
Last Updated
August 8, 2018
Record last verified: 2018-08