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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439790
• Other study ID #: 0602508
• Status: Completed
• Phase: N/A
• First received: February 23, 2007
• Last updated: June 12, 2012
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart failure patient with an ICD

Exclusion Criteria:

• Pregnant patient

• Acute coronary syndrome within the last 3 months

• Peripheral neuropathy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac
• Heart Failure

Intervention

Procedure:
• Microneurography
Microneurography

Locations

Country	Name	City	State
France	Cardiologie, University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France,