Comparison of hemodynamic effects of biventricular versus left ventricular only pacing in patients receiving cardiac resynchronization therapy: a before-after clinical trial
Objectives: To assess hemodynamic effects of biventricular versus left ventricular only pacing in patients receiving Cardiac Resynchronization Therapy Design: A before-after clinical trial Setting and conduct: All patients with CRT who refer to electrophysiological clinic of Ekbatan hospital for programing in 2012 Participants including major eligibility criteria: All patients with CRT will be included unless they have not responded to CRT. Intervention: In intervention group, the CRT pacemaker will be set for left ventricular only pacing for three month. In control group, the CRT pacemaker will be left as biventricular pacing for three months. Main outcome measures: The hemodynamic status of the patients will be assess at baseline and three months later as follows: (a) Velocity Time Integral (VTI) of aortic valve per cm; (b) Left Ventricular End Diastolic Volume (LVEDV) of aortic valve per ml; (c) Left Ventricular End Systolic Volume (LVESV) of aortic valve per ml; (d) Left Ventricular Ejection Fraction (LVEF) of aortic valve per percent
General information
Acronym
CRT: Cardiac Resynchronization Therapy
IRCT registration information
IRCT registration number:IRCT201203169014N7
Registration date:2012-07-02, 1391/04/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-02, 1391/04/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic effects of biventricular versus left ventricular only pacing in patients receiving cardiac resynchronization therapy: a before-after clinical trial
Public title
Comparison of hemodynamic effects of biventricular versus left ventricular only pacing in patients receiving Cardiac Resynchronization Therapy (CRT)
Purpose
Treatment
Inclusion/Exclusion criteria
All patients with CRT will be included unless they have not responded to CRT.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
D/P/16/35/9/1114
Health conditions studied
1
Description of health condition studied
Cadiac Resynchronization Therapy (CRT)
ICD-10 code
I49
ICD-10 code description
Other cardiac arrhythmias
Primary outcomes
1
Description
Four variables will be considered for assessing hemodynamic status of the patientsat baseline, three and six month later including: (a) Velocity Time Integral (VTI) of aortic valve per cm; (b) Left Ventricular End Diastolic Voliume (LVEDV) of aortic valve per mL/m2; (c) Left Ventricular End Systolic Voliume (LVESV) of aortic valve per mL/m2; (d) Left Ventricular Ejection Fraction (LVEF) of aortic valve per percent.
Timepoint
3 months
Method of measurement
Ecocardiography
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, the CRT pacemaker will be set for left ventricular only pacing for three months
Category
Treatment - Devices
2
Description
In control group, the CRT pacemaker will be left as biventricular pacing for three months
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Dr Babak Faghfurian
Street address
Department of Cardiology, School of Medicine
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan 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
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Cardiology, School of Medicine
Full name of responsible person
Dr Babak Faghfurian
Position
MD, Assistant Professor of Cardiology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
00
Fax
Email
babak_sgn@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)