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OpenTrials
Completed

NCT Number: NCT02930382

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU DE Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baroreflex assessment

Other

Primary outcomes

  1. spontaneous baroreflex sensitivity by the sequence method (mean slope)

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: BARODEF

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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