The aim of this study is assessment of effect of prophylactic carvedilol on incidence of heart failure in patients with breast cancer receiving herceptin or anthracylines. The study population is HER2 positive breast cancer patients. The sample volume is 50 patients. The study is double blind. Breast cancer patients are randomly divided into two groups using randomised permuted blocks. After baseline speckle tracking echocardiography, the intervention group will receive carvedilol with dose 6.25 mg two times a day 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:IRCT2017042433619N1
Registration date:2017-07-05, 1396/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Saeed Nourian
Name of organization / entity
Baqiyatallah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 5396
Email address
s-nourian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanceller for research, Baqiatallah University of Medical Sciences.
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2018-01-01, 1396/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Treatment with Carvedilol in Preventing Heart failure in breast cancer patients under treatment with herceptin or anthracyclines.
Public title
Assessment the effect of Carvedilol in preventing Heart failure in breast cancer patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: breast cancer patients under treatment with herceptin or antracyclines.
Exclusion criteria: EF less than50%; Significant Valvular Heart Disease; GFR<30ml/h/m2; Hepatic Failure; Contraindications for beta blockers; Symptoms of Heart Failure.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of randomization is randomised permuted blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Mollasadra Street
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.BMSU.REC.1394.244
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Left and Right Ventricule Function
Timepoint
3 months after treatment
Method of measurement
Speckle Tracking Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Carvedilol 6.25 mg tablet, 12.5 mg two times a day, for 3 months or until the time of heart failure symptoms development.
Category
Treatment - Drugs
2
Description
Control group: No Drug
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Saeed Nourian
Street address
Mollasadra street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Baqiyatallah University of Medical Sciences
Full name of responsible person
Doctor Alishiri
Street address
Mollasadra street.
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 for research of Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Saeed Nourian
Position
Cardiologist
Other areas of specialty/work
Street address
Mollasadra street.
City
Tehran
Postal code
Phone
+98 21 8248 3347
Fax
Email
S-nourian@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Saeed Nourian
Position
Cardiologist
Other areas of specialty/work
Street address
Mollasadra street.
City
Tehran
Postal code
Phone
+98 21 8248 3347
Fax
Email
S-nourian@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Saeed Nourian
Position
Cardiologist
Other areas of specialty/work
Street address
Mollasadra Street.
City
Tehran
Postal code
Phone
+98 21 8248 3253
Fax
Email
s-nourian@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)