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

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488410
• Other study ID #: CHU63-0016
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: September 6, 2010
• Start date: November 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Doppler echocardiography

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.