SYNCHRO. Evaluation of the Forecasts Parameters of Real T... | NCT00488410

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 18, 2007

First Submission Date that Met QC Criteria

Jun 19, 2007

First Posted Date

Jun 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2010

Last Update Posted Date

Sep 8, 2010Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Doppler echocardiography	Device

Measure	Description	Time Frame
Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Citron, Pr	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clermont-Ferrand University Hospital		Clermont-Ferrand	Auvergne	63000	France

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014463	Ultrasonography
D018608	Ultrasonography, Doppler
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular