SYNCHRO. Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
This study has been completed.
Sponsor:
University Hospital, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00488410
First received: June 18, 2007
Last updated: September 6, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Heart Failure |
Device: Doppler echocardiography |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Single Blind |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patient without social insurance policy
- Drug or alcohol addiction
- Any psychological disorder
- Pregnant women
- Patient with a transplanted organ
- HIV positive serology at inclusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488410
Locations
| France | |
| Clermont-Ferrand University Hospital | |
| Clermont-Ferrand, Auvergne, France, 63000 | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
| Principal Investigator: | Bernard Citron, Pr | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | CHU Clermont-Ferrand, Cardiac surgery center |
| ClinicalTrials.gov Identifier: | NCT00488410 History of Changes |
| Other Study ID Numbers: | CHU63-0016 |
| Study First Received: | June 18, 2007 |
| Last Updated: | September 6, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Chronic heart failure real time three-dimensional echocardiography cardiac resynchronization therapy ventricular asynchrony systolic dysynchrony index |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013