- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439790
Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients
June 12, 2012 updated by: University Hospital, Toulouse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
109
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toulouse, France, 31400
- Cardiologie, University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Heart failure patient
Description
Inclusion Criteria:
- Heart failure patient with an ICD
Exclusion Criteria:
- Pregnant patient
- Acute coronary syndrome within the last 3 months
- Peripheral neuropathy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Atul Pathak, MD, Hospital University Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
February 23, 2007
First Submitted That Met QC Criteria
February 23, 2007
First Posted (ESTIMATE)
February 26, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0602508
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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