NCT00439790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

First QC Date

February 23, 2007

Last Update Submit

June 12, 2012

Conditions

Heart FailureDeath, Sudden, Cardiac

Keywords

implantable cardioverter defibrillatorHeart failureSudden Cardiac Arrestappropriate shockDefibrillators, Implantable

Interventions

MicroneurographyPROCEDURE

Microneurography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patient

You may qualify if:

  • Heart failure patient with an ICD

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiologie, University Hospital

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Heart FailureDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Atul Pathak, MD

    Hospital University Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

January 1, 2007

Study Completion

December 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

FR(1)