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

September 6, 2010 updated by: University Hospital, Clermont-Ferrand

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63000
        • Clermont-Ferrand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Bernard Citron, Pr, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 6, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU63-0016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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