Clinical trial NCT00488410: SYNCHRO. Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic heart failure
real time three-dimensional echocardiography
cardiac resynchronization therapy
ventricular asynchrony
systolic dysynchrony index
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-06-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Bernard Citron, Pr
role: PRINCIPAL_INVESTIGATOR
References: