2 arm parellel group randomised trial ,single blinded,with group control and another intervention group ,70 patients ,phase 2,simple randomization method,our randomization was based on the last number of national identification number being odds or evens.
Settings and conduct
70 patients were included to our study from oncology ward and cancer research center of rasool akram hospital,blinded for responsibles for echocardiography and data collection and analysis,divided in two groups ,intervention group patients were treated with bisoprolol,and echocardiography was done for both groups at first and 6 mouths after termination of chemotherapy
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. cancer patients treated with Anthracyclines 2.age more than 40 years old 3.having no PMH of heart disease
exclusion criteria:1,LVEF less than 45 %,2.using other cardiovascular medications
Intervention groups
Intervention group included 35 cancer patients treated with Transtuzumab ,Docetaxel ;who were treated with bisoprolol
Control group included 35 cancer patients treated with Transtuzumab ,Docetaxel ;who were not treated with bisoprolol
Main outcome variables
1.Lv diastolic function by transthoracic echocardiography
2.Lv systolic function by transthoracic echocardiography
3.Global longitudinal strain echocardiography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240609062050N1
Registration date:2024-06-23, 1403/04/03
Registration timing:retrospective
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
Registrant information
Name
ماه mah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 6918
Email address
hajahmadipour.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
2022-04-04, 1401/01/15
Actual recruitment end date
2022-10-23, 1401/08/01
Trial completion date
2024-02-20, 1402/12/01
Scientific title
Evaluation of the effect of bisoprolol on the prevention of heart failure in cancer patients treated with anthracyclines
Public title
Evaluation of preventive effect of bisoprolol in sub clinical Heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
cancer patients treated with anthracyclines
LVEF>45 %
not using other drugs for heart problems
Exclusion criteria:
known case of heart disease
LVEF less than 45 percent
age below 40
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
63
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization,our randomization was based on the last number of national identification number being odds or evens.
Blinding (investigator's opinion)
Single blinded
Blinding description
one-sided blind study and those who are blinded are:
1. Responsibles for data collection and analysis; 2. those who evaluate the outcome.
3. Responsibles for echocardiography of patients in the specialized echocardiography department.
Non-blind people include:The participants and the person responsible for caring and following up the patients
Placebo
Not used
Assignment
Other
Other design features
Evaluation of sub clinical hear failure by GLS method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran university of medical sciences
Street address
Tehran ,Hemat freeway ,Iran university of medical siences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.IUMS.FMD.REC.1400.197
Health conditions studied
1
Description of health condition studied
Heart failure caused by treatment with anthracyclines
ICD-10 code
142.7
ICD-10 code description
کاردیومیوپاتی ناشی از مصرف داروهای شیمی درمانی دسته انتراسایکلین ها
Primary outcomes
1
Description
systolic function in TTE
Timepoint
before starting the study ,and then 6 mouths after the end of the chemotherapy
Method of measurement
LV systolic function in TTE by Simpson method
2
Description
diastolic Lv function
Timepoint
at the begining ,and then 6 mouths after the end of chemotherapy
Method of measurement
LV diastolic function in TTE
3
Description
LV global longitudinal strain by strain echocardiography
Timepoint
at the begining ,and the 6 mouths after the end of chemotherapy
Method of measurement
by strain echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 28 patients were treated with bisoprolol 1/25 mg (from MERCK company BRAND NAME CONCOR)at the begining and the optimize the drug dose until 2/5 mg per day with control of patients HR and Bp every other week ;8 patients were excluded due to non compliance at first the intervention group include 35 patients.and echo cardiography was done at the begining and 6 mouths after termination of chemotherapy
Category
Treatment - Drugs
2
Description
Control group: 35 patients in group control no intervention was done,only echocardiography at the begining and 6 mouths after the termination of chemotherapy.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Healt& cancer research center
Full name of responsible person
Dr Nahid nafisi
Street address
niyayesh street ,rasool akram hospital ,breast and health& cancer research center
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
breastdiseasecancerresearch@gmail.com
2
Recruitment center
Name of recruitment center
Rasool akram hospital ,oncology ward
Full name of responsible person
Mah hedayati emami
Street address
niyayesh street,rsool akram hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasoolhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mah hedayati emami
Street address
Satarkhan,niyayesh street ,rasool akram hospital cardiology ward
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasoolhospital@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?