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

NCT ID: NCT00439790

Last Updated: 2012-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-12-31

Brief 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

Heart Failure; Death, Sudden, Cardiac

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Microneurography

Microneurography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Heart failure patient with an ICD

Exclusion Criteria

• Pregnant patient
• Acute coronary syndrome within the last 3 months
• Peripheral neuropathy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atul Pathak, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Toulouse

Locations

Cardiologie, University Hospital

Toulouse, , France

Countries

France

Other Identifiers

0602508

Identifier Type: -

Identifier Source: org_study_id