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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler echocardiography

Device

Primary outcomes

  1. Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2007
Registry last updated
Sep 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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