The aim of this study is assessment of effect of prophylactic carvedilol on incidence of heart failure in patients with HER2 positive breast cancer receiving herceptin. The inclusion criteria was all HER2 positive breast cancer patients who are candidate for receiving herceptin. The exclusion criteria was history of heart failure, concomitant anthracycline therapy,and history of coronary artery disease.The study population is HER2 positive breast cancer patients.The sample volume is 100 patients.The study is double blind.Patients are randomly divided into two groups.After baseline echocardiography,the case group will receive carvedilol and the control group will receive placebo for 3 months or up to the time when symptoms of heart failure would develop.The primary outcome is development of heart failure symptoms or reduction in LVEF at the end of 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112019840N1
Registration date:2015-02-21, 1393/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-21, 1393/12/02
Registrant information
Name
Alborz Sherafati
Name of organization / entity
Tehran university of medical sciences,Imam Khomeini hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9537
Email address
asherafati@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran university of medical sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assessment of prophylactic treatment with carvedilol in incidence of heart failure in patients with HER2 positive breast cancer receiving trastuzumab
Public title
Effect of carvedilol in preventing heart failure following herceptin therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:patients with HER2 positive breast cancer who are candidate for herceptin therapy
Exclusion: history of systolic heart failure (EF<50), history of anthracycline therapy,contraindications for beta blockers, history of coronary artery disease,symptoms of heart failure including orthopnea or PND or dyspnea on exertion
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The randomization method is by randomized permuted blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran university of medical sciences
Street address
Poursina street,18th of Azar avenue, Keshavarz blvd
City
Tehran
Postal code
Approval date
2014-06-20, 1393/03/30
Ethics committee reference number
9111171017
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
heart failure
Timepoint
3 months after administration of herceptin
Method of measurement
echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:Tab Carvedilol 6.25-12.5 mg bid for 3 months or up to the time when symptoms of heart failure develop
Category
Treatment - Drugs
2
Description
Control:placebo with the same dose and duration of carvedilol therapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Alborz Sherafati
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research of Tehran university of medical scienses
Full name of responsible person
DR Yonesian
Street address
Imam Khomeini Hospital, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research of Tehran university of medical scienses
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
Imam Khomeini hospital
Full name of responsible person
Alborz Sherafati
Position
resident of cardiology
Other areas of specialty/work
Street address
Keshavarz blvd
City
Tehran
Postal code
Phone
+98 21 6693 9537
Fax
Email
asherafati@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Alborz Sherafati
Position
resident of cardiology
Other areas of specialty/work
Street address
keshavarz blvd
City
tehran
Postal code
Phone
+98 21 6693 9537
Fax
Email
asherafati@student.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Alborz Sherafati
Position
resident of cardiology
Other areas of specialty/work
Street address
keshavarz blvd
City
tehran
Postal code
Phone
+98 21 6693 9537
Fax
Email
asherafati@student.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)