Protocol summary

Summary
Cardiac resynchronization therapy is beneficial for a majority of patients with medically refractory heart failure due to severe LV systolic dysfunction and prolonged interventricular conduction to optimally programmed Atrioventricular delay during CRT can be also important to maximize the response in left ventricular function.several echocardiographic method have been reported to be useful for determination of the optimal AVD .In this trial 40 patient with left ventricular systolic dysfunction, will be randomized in a fixed AV delay(factory suggested)and AV delay determined by echocardiography(inclusion criteria:patient with systolic left ventricular dysfunction; Ejection fraction<35%; sinus rhythm;function class 3or4 with medical therapy; QRS duration>120ms ).patient will be evaluated by echocardiography and clinical status prior to initiation of CRT and 2 month post implant.we want to comparison function class of patient (primary out come measure)between two group of them.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102232474N3
Registration date: 2011-09-28, 1390/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-28, 1390/07/06
Registrant information
Name
Mehdi Toluey Khormazard
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1668 6560
Email address
drmtoluey@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tabriz university of medical sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of three chamber pacemaker in patients with systolic dysfunction, on sign and symptom when its programmed based on echo cardiography versus factory suggested
Public title
Comparison of programmed parameters of three chamber pacemaker based on echocardiographic finding versus factory suggested parameters
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patient with systolic left ventricular dysfunction; Ejection fraction<35%; sinus rhythm;function class 3or4 with medical therapy; QRS duration>120ms. exclusion criteria:severe structural valvular disease;Intra cardiac shunt
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
5.4.9588

Health conditions studied

1

Description of health condition studied
Left Ventricular Systolic Dysfunction
ICD-10 code
I42.0
ICD-10 code description
Dilated Cardiomyopathy

Primary outcomes

1

Description
Function Class
Timepoint
Befor intervention and two month after intervention
Method of measurement
6min walk

Secondary outcomes

1

Description
Left Ventricular Function
Timepoint
Befor intervention and two month after intervention
Method of measurement
Echocardiography

Intervention groups

1

Description
Intervention:After implantation of three chamber pace maker " device is programmed on echo cardiography guided and patient should be followed after 2 month.
Category
Treatment - Devices

2

Description
Control:in this group after implantation of pace maker , device is programmed on factory consults and patient followed after 2 month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madany Heart Center
Full name of responsible person
Dr Ali Abbasnejad
Street address
Madani hospital, Golgasht st, Azadi st
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Tabriz University of Medical Sciences
Full name of responsible person
Dr Rasool Azarfarin
Street address
Tabriz University of Medical Scienc, Golgasht street, Azadi street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariborz Akbarzadeh
Position
Professor
Other areas of specialty/work
Street address
Shahid Madani Hospital, Golgasht street, Azadi street, Tabriz
City
Tabriz
Postal code
Phone
+98 914 114 2328
Fax
Email
F_AKBARZADEH@Yahoo.Com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariborz Akbarzadeh
Position
Professor
Other areas of specialty/work
Street address
Shahid Madani Hospital, Golgasht street , Azadi Street, Tabriz
City
Tabriz
Postal code
Phone
+98 914 114 2328
Fax
Email
F_AKBARZADEH@Yahoo.Com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of medical Sciences
Full name of responsible person
Ali Abbasnejad
Position
Cardiology Assistant
Other areas of specialty/work
Street address
Tabriz University, Golgasht street, Azadi street, Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
dr.abbasnezhad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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