Clinical Trials Directory

Trials / Completed

CompletedNCT00439790

Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients

Validation of a Prognostic Score to Identify Heart Failure Patients Who Might Need an Implantable Cardioverter Defibrillator Using Muscle Sympathetic Nerve Activity and Autonomic Testing

Status
Completed
Phase
Study type
Observational
Enrollment
109 (actual)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

Detailed description

We plan to perform an extensive study of the sympathetic nervous system activity in heart failure patients with an ICD. The SNS activity will be measured directly by a recording of the muscle sympathetic nerve activity and indirectly by post processing of 24-hour Holter recording, catecholamine levels assessment, and spontaneous baroreflex sensitivity. A global assessment of the patients status will also be realised. Patients will be followed for one year. During follow up, this cohort will be divided into two groups according to the occurrence or not of an appropriate shock. We assume that an appropriate shock is a surrogate marker for sudden cardiac death. We plan to compare the autonomic nervous system activity in both groups of patients in order to identify a score able to detect heart failure patients at high risk for sudden cardiac death.

Conditions

Interventions

TypeNameDescription
PROCEDUREMicroneurographyMicroneurography

Timeline

Start date
2007-01-01
Completion
2011-12-01
First posted
2007-02-26
Last updated
2012-06-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00439790. Inclusion in this directory is not an endorsement.