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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02930382
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: Baroreflex assessment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Actual Study Start Date: May 26, 2016
• Actual Primary Completion Date: May 26, 2016
• Actual Study Completion Date: May 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAROREFLEX	Other: Baroreflex assessment

Outcome Measures

Primary Outcome Measures

1. spontaneous baroreflex sensitivity by the sequence method (mean slope) [10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU DE Poitiers	Poitiers		France	86021

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT02930382
• Other Study ID Numbers: BARODEF
• First Posted: Oct 12, 2016
• Last Update Posted: Aug 8, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of Aug 8, 2018