Heart FailureNCT00439790
Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients
An observational study of Heart Failure and Death, Sudden, Cardiac, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Death, Sudden, Cardiac
- What is being tested?
- Microneurography
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patient
Who may be able to join
- Heart failure patient with an ICD
Who cannot join
- Pregnant patient
- Acute coronary syndrome within the last 3 months
- Peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Death, Sudden, Cardiac
- Being tested
- Microneurography
- Keywords
- implantable cardioverter defibrillator, Heart failure, Sudden Cardiac Arrest, appropriate shock, Defibrillators, Implantable
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneurographyProcedure or surgery
Microneurography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startJan 2007
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atul Pathak, MD, Principal investigator, Hospital University Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439790
- Sponsor's protocol ID
- 0602508
- Status last verified
- Jun 2012
- First submitted
- 23 Feb 2007
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00439790
- Acronym / sponsor ID
- 0602508
- Conditions
- Heart Failure, Death, Sudden, Cardiac
- Keywords
- implantable cardioverter defibrillator, Heart failure, Sudden Cardiac Arrest, appropriate shock, Defibrillators, Implantable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patient
Key inclusion criteria (1 listed)
- Heart failure patient with an ICD
Key exclusion criteria (3 listed)
- Pregnant patient
- Acute coronary syndrome within the last 3 months
- Peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneurographyMicroneurography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Pathak, MD principal investigator
Hospital University Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Death, Sudden, Cardiac, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.