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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439790
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment
Heart Failure Death, Sudden, Cardiac Procedure: Microneurography

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.

Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 2007
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Microneurography

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patient

Inclusion Criteria:

  • Heart failure patient with an ICD

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439790

Cardiologie, University Hospital
Toulouse, France, 31400
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Atul Pathak, MD Hospital University Toulouse

Responsible Party: University Hospital, Toulouse Identifier: NCT00439790     History of Changes
Other Study ID Numbers: 0602508
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by University Hospital, Toulouse:
implantable cardioverter defibrillator
Heart failure
Sudden Cardiac Arrest
appropriate shock
Defibrillators, Implantable

Additional relevant MeSH terms:
Heart Failure
Death, Sudden
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest