Chronic Heart FailureNCT00488410
SYNCHRO. Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
A study testing Doppler echocardiography in people with Chronic Heart Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Doppler echocardiography
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2006to Dec 2009
- Phase
- Interventional
- 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
Who may be able to join
- Both gender
- Age>18 years
- Patients in functional class NYHA III or IV
- Patient with ejection fraction <or=150msec or with QRS between 120 and 149 msec but with echocardiographic evidences for cardiac dyssynchrony, such as those retained in the CARE-HF trial, e.g.two from the three following criterions :-Aortic pre-ejection delay>140msec
- Interventricular mechanical delay >40msec
- Delayed activation of the left ventricular postero-lateral wall
- Patient under optimal treatment for chronic heart failure for at least one month before inclusion
- Written informed consentement
Who cannot join
- Patient with atrial fibrillation
- Absence of echogenicity
- Patient with an indication for pacemaker implantation
- Patient suffering from arterial pressure disorders, with systolic pressure greater than 170 or lower than 80 mmHg
- Major cardiovascular event within 6 weeks before inclusion
- Patient in the exclusion period of any other clinical trial
Show all 12Show fewer
- Patient without social insurance policy
- Drug or alcohol addiction
- Any psychological disorder
- Pregnant women
- Patient with a transplanted organ
- HIV positive serology at inclusion
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
About this study
Official title: Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode.
Read the detailed description
Patients with a pathological SDI (> 8%) will as usually be treated by CRT and will serve as control group. The study duration for each patient included in the trial is 6 months. Patients showing a decreased NYHA score by at least one class and an absence of major cardiovascular event during the period will be considered as "good responders". The otherswill be considered as "no responders".
Based on this composite clinical score, the percentage of good responders in each group at 6 months is the primary endpoint of the study.
Main secondary endpoints :
- Evaluation of the left ventricular function
- Exercice capacity
- Serious adverse events'frequency
- Quality of life (SF36)
- Diagnostic and prognostic value of the "Brain Natriuretic Peptide"(NT pro BNP)evolution.
- Conditions
- Chronic Heart Failure
- Being tested
- Doppler echocardiography
- Keywords
- Chronic heart failure, real time three-dimensional echocardiography, cardiac resynchronization therapy, ventricular asynchrony, systolic dysynchrony index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler echocardiographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Bernard Citron, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488410
- Sponsor's protocol ID
- CHU63-0016
- Status last verified
- Sep 2010
- First submitted
- 18 Jun 2007
- Last updated
- 8 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT00488410
- Acronym / sponsor ID
- CHU63-0016
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic heart failure, real time three-dimensional echocardiography, cardiac resynchronization therapy, ventricular asynchrony, systolic dysynchrony index
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Jun 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.
Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode.
Detailed description
Patients with a pathological SDI (> 8%) will as usually be treated by CRT and will serve as control group. The study duration for each patient included in the trial is 6 months. Patients showing a decreased NYHA score by at least one class and an absence of major cardiovascular event during the period will be considered as "good responders". The otherswill be considered as "no responders".
Based on this composite clinical score, the percentage of good responders in each group at 6 months is the primary endpoint of the study.
Main secondary endpoints :
- Evaluation of the left ventricular function
- Exercice capacity
- Serious adverse events'frequency
- Quality of life (SF36)
- Diagnostic and prognostic value of the "Brain Natriuretic Peptide"(NT pro BNP)evolution.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both gender
- Age>18 years
- Patients in functional class NYHA III or IV
- Patient with ejection fraction <or=150msec or with QRS between 120 and 149 msec but with echocardiographic evidences for cardiac dyssynchrony, such as those retained in the CARE-HF trial, e.g.two from the three following criterions :-Aortic pre-ejection delay>140msec
- Interventricular mechanical delay >40msec
Key exclusion criteria (12 listed)
- Patient with atrial fibrillation
- Absence of echogenicity
- Patient with an indication for pacemaker implantation
- Patient suffering from arterial pressure disorders, with systolic pressure greater than 170 or lower than 80 mmHg
- Major cardiovascular event within 6 weeks before inclusion
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 |
|---|---|---|
| Doppler echocardiography | Device | – |
Primary outcome
Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
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 8 Sep 2010.
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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.
Bernard Citron, Pr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler echocardiography in people with Chronic Heart Failure, run by University Hospital, Clermont-Ferrand 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 8 inclusion and 12 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 8 Sep 2010. 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.
What does the primary outcome measure?
Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.. It is what the study was designed to measure, not a finding.
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 8 Sep 2010.