SYNCHRO. Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy

Study Overview
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Brief Summary
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Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in ON or OFFmode 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
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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.

Official Title
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Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Doppler echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Doppler echocardiography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic heart failure, real time three-dimensional echocardiography, cardiac resynchronization therapy, ventricular asynchrony, systolic dysynchrony index