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

NCT ID: NCT02930382

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-26

Study Completion Date

2016-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BAROREFLEX

Group Type EXPERIMENTAL

Baroreflex assessment

Intervention Type OTHER

Interventions

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Baroreflex assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU DE Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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BARODEF

Identifier Type: -

Identifier Source: org_study_id

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