SYNCHRO. 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.
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488410
|Clermont-Ferrand University Hospital|
|Clermont-Ferrand, Auvergne, France, 63000|
|Principal Investigator:||Bernard Citron, Pr||University Hospital, Clermont-Ferrand|