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NCT02930382 Clinical Trial

Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study

Myocardial Infarction Clinical Trial

— BARODEF  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02930382
Other study ID # BARODEF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2016
Est. completion date May 26, 2016

Study information
Verified date August 2018
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date May 26, 2016
Est. primary completion date May 26, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Baroreflex assessment

Locations
Country Name City State
France CHU DE Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary spontaneous baroreflex sensitivity by the sequence method (mean slope) 10 days
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