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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00488410
First received: June 18, 2007
Last updated: September 6, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Device: Doppler echocardiography

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488410

Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Bernard Citron, Pr University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: CHU Clermont-Ferrand, Cardiac surgery center
ClinicalTrials.gov Identifier: NCT00488410     History of Changes
Other Study ID Numbers: CHU63-0016
Study First Received: June 18, 2007
Last Updated: September 6, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Chronic heart failure
real time three-dimensional echocardiography
cardiac resynchronization therapy
ventricular asynchrony
systolic dysynchrony index

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014