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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02930382

Acronym

BARODEF

Enrollment

Registered

2016-10-12

Start date

2016-05-26

Completion date

2016-05-26

Last updated

2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

OTHERBaroreflex assessment

Study design

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
spontaneous baroreflex sensitivity by the sequence method (mean slope)	10 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026