The aim of this study was evaluation of carvedilol effect on left ventricular function in patient who treated with herceptin and its role in prevention of heceptin induced cardiomyopathy. inclusion criteria was patient with breast cancer candidate for herceptin therapy due to positive HER 2 without attention to previous chemotherapy that have ejection fraction >50% and normal diastolic function or mild dysfunction
exclusion criteria:patient who have contraindication for carvedilol .study population: 50 patient treated with herceptin for one year .25 patient will randomly receive carvedilol .All patient will evaluated by echocardiography 7 days before treatment ,3,6 ,12 months after that. primary out come is development of left ventricular dysfunction .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062922968N1
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Elmira Aghaeei
Name of organization / entity
Hamadan Medical Univercity
Country
Iran (Islamic Republic of)
Phone
+98 38260174
Email address
e.aghaeei@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
EKBATAN HOSPITAL
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Carvedilol effect on LV function in patients treated with Herceptin due to breast cancer
Public title
Effect of Carvedilol on Heart function
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
all of patient with breast cancer candidate for Herceptin therapy without attention to previous chemotherapy that have Ejection Fraction >50% and normal diastolic function or mild dysfunction
exclusion criteria:patient who have contraindication for Carvedilol;grade 2or 3 AV block; Heart rate <50;systolic blood pressure<90;Asthma;chronic obstructive pulmonary disease ;liver cirrhosis;psoriasis; peripheral vascular disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Pajuhesh blv, Hamedan, Iran
City
Hamedan
Postal code
۶۵۱۷۶۱۹۶۵۱
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.123
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50-C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Left ventriculare dysfunction
Timepoint
Before chemotherapy and 3-6-12 month after thet
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
":Intervention group: " Tab Carvedilol 6/25 mg bid for 1 year
Category
Treatment - Drugs
2
Description
Control group: Nothing
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Elmira Aghaeei
Street address
Ekbatan Hospital, Hamedan, Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Dr Homayounfar
Street address
Ekbatan Hospital, Hamedan, Iran
City
Hamedan
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 of Hamedan 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
Ekbatan Hospital
Full name of responsible person
Elmira Aghaee
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3825 1244
Fax
Email
e.aghaeei@edu.umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ekbatan Hospital
Full name of responsible person
Elmira Aghaee
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3825 1244
Fax
Email
e.aghaeei@edu.umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ekbatan Hospital
Full name of responsible person
Elmira Aghaee
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3825 1244
Fax
Email
e.aghaeei@edu.umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)