Our aim of this study is to evaluate of left ventricular contractile reserve by stress echocardiography with milrinone in patients with advanced heart failure who have candidated for a treatment named Cardiac Resynchronization Therapy (CRT), an implantable device.30 subjects with advanced heart failure who have left ventricular ejection fraction equivalent or less than 35%, Left bundle branch block with sinus rhythm, wideness of QRS more than 120msec, NIHA (New York Heart Association) functional class 3 & 4 and poor response to medical therapy (Inclusion criteria), will select and undergo Milrinone Stress Echocardiography for evaluate left ventricular contractile reserve before device implantation and 4 to 6 months later by routine echocardiography. Comparison response to Milrinone with response to device , will reveal predictor rule of Milrinone drug. Primary outcome is improvement left ventricular contractility according to echocardiographic values specially left ventricular ejection fraction, end diastolic volume, and end systolic volume. Other out comes include functional capacity on base of history and 6 minutes walk distance and finally frequency of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201238808N1
Registration date:2012-03-18, 1390/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-18, 1390/12/28
Registrant information
Name
Karim Mohammadi Kheyrabadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3880
Email address
kheyrabadikm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of contractile reserve by Milrinone as a predictor of response to Cardiac Resynchronization Therapy in patients with heart failure.
Public title
Prediction of CRT implantation benefit with Milrinone stress echocardiography
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Heart failure patients who have LBBB with sinus rhythm, QRS>120msec, LVEF<35%, NIHA function class 3 & 4 and poor response to medical therapy.
Exclusion criteria: Hypersensitivity to Milrinone,AF rhythm,severe COPD, hypertrophic and restrictive cardiomyopathies, acute myocarditis, correctable valvular diseases and acute coronary syndrome.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Daneshgah street, Tabriz
City
Tabriz
Postal code
Approval date
2011-05-30, 1390/03/09
Ethics committee reference number
1949/4/5
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Echocardiographic Values of left ventricular contractility
Before CRT implantation and after performing basic echocardiography, drug administrating ( Milrinone ) with loading dose 50 microgram/kg BW in 10 miuntes and continuing 5 microgram/kg/minute for 10 to15 miuntes intravenously infusion,after repeating echocardiography drug will discotinue
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shahid Madani Hospital
Full name of responsible person
Karim Mohammadi Kheyrabadi
Street address
Daneshgah Street, Tabriz Shahid Madani Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Research Center
Street address
Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?