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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00439790
First received: February 23, 2007
Last updated: June 12, 2012
Last verified: June 2012

February 23, 2007
June 12, 2012
January 2007
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Complete list of historical versions of study NCT00439790 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Heart failure patient

  • Heart Failure
  • Death, Sudden, Cardiac
Procedure: Microneurography
Microneurography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
December 2011
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Inclusion Criteria:

  • Heart failure patient with an ICD

Exclusion Criteria:

  • Pregnant patient
  • Acute coronary syndrome within the last 3 months
  • Peripheral neuropathy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00439790
0602508
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Atul Pathak, MD Hospital University Toulouse
University Hospital, Toulouse
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP