SYNCHRO. Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
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|ClinicalTrials.gov Identifier: NCT00488410|
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : September 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Device: Doppler echocardiography||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|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 Start Date :||November 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
- Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488410
|Clermont-Ferrand University Hospital|
|Clermont-Ferrand, Auvergne, France, 63000|
|Principal Investigator:||Bernard Citron, Pr||University Hospital, Clermont-Ferrand|