Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib in Sari city
Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib in Sari city
Design
The process of random allocation is provided by block method. This process will be done with Random Allocation Software. The ratio of allocation of samples between the two groups is 1:1. 30 samples.
Settings and conduct
oncology clinic at Imam Khomeini Hospital in Sari
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with CML treated with nilotinib and dasatinib for at least 1 y
Age > 18 y
Sinus rhythm of the heart
Criteria for not entering the study:
acute or chronic heart failure
Low ejection fraction in echocardiography
history of valvular heart disease or congenital heart disease;
Systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg.
PR interval ≥ 240 ms
second or third degree AV block
History of asthma
chronic obstructive pulmonary disease (COPD)
and previous medical history of cardioprotective drugs (such as ACE inhibitors or dexrazoxane)
Previous diagnosis of cardiomyopathy, history of CAD moderate to severe mitral and aortic disease, and AF
consent to participate in the study
Intervention groups
Study subjects were divided into 2 control groups (patients with chronic myeloid leukemia treated with nilotinib and dasatinib who did not receive carvedilol) and intervention group (patients with chronic myeloid leukemia treated with nilotinib and dasatinib who received carvedilol)
Main outcome variables
LVEF level,
Pro-BNP level
Troponin level
Change GLS
Diameter of the left atrium
Left ventricular systole and diastole diameter
The thickness of the septum and the posterior wall of the left ventricle
Initial mitral inflow velocity and delay
The ratio of inflow velocity and mitral initial delay
mitral inflow slowing time
Pulmonary artery pressure
QT Intertval
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241013063353N1
Registration date:2025-12-29, 1404/10/08
Registration timing:prospective
Last update:2025-12-29, 1404/10/08
Update count:0
Registration date
2025-12-29, 1404/10/08
Registrant information
Name
ali bazram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3434 3000
Email address
a.bazram@mazums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2027-02-20, 1405/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib in Sari city
Public title
Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic myeloid leukemia treated with nilotinib and dasatinib for at least one year
Age>18
Sinus rhythm of the heart
Exclusion criteria:
Acute and Chronic Heart Failure
Low Ejection Fraction
History of valvular heart disease or congenital heart disease
Systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg
PR interval ≥ 240 ms
AV block grade 2-3
History of Asthema
Chronic Obsteractive Pulmonary Disease
Previous medical history of cardioprotective drugs (such as ACE inhibitors or dexrazoxane)
Previous diagnosis of cardiomyopathy, history of coronary artery disease, moderate to severe mitral and aortic disease, and atrial fibrillation.
Lack of consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The process of random allocation is provided by block method. This process will be done with Random Allocation Software. The ratio of allocation of samples between the two groups is 1:1. With the mentioned software, the number and size of blocks are determined by default to allocate 30 samples. The block size will be a multiple of 4 and 6. Samples that meet the inclusion criteria are included in the study based on randomly generated numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the data analyst is blinded. And other people including the researcher, participants (patients included in the study) are aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran university of medical sciences
Street address
Vice chancellor for research and technology, Moalem Sq, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2025-01-23, 1403/11/04
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1403.114
Health conditions studied
1
Description of health condition studied
chronic myeloid leukemia
ICD-10 code
C92.1
ICD-10 code description
Chronic myeloid leukemia, BCR/ABL-positive
Primary outcomes
1
Description
Study of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib in Sari city.
Timepoint
Outcomes are measured at 0, 6, and 12 months.
Method of measurement
Based on echocardiography by an echocardiogram specialist and measurement of cardiac-specific biomarkers ProBNP, Troponin I
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib undergoing carvedilol intervention
Category
Treatment - Drugs
2
Description
Control group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib without intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ramin Shekarriz
Street address
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomini hospital, Amir Mazandarani Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 4044
Email
r.shekarriz@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Jalal Ahmadi
Street address
Vice chancellor for research and technology, Moalem Sq, Sari, Iran
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
a.bazram@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Bazram
Position
Internal Medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166234356
Phone
+98 11 4204 0905
Email
ali_next@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ramin Shekarriz foumani
Position
Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166234356
Phone
+98 11 3336 4044
Email
drraminshekarriz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Bazaram
Position
internal medicine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 4204 0905
Email
ali_next@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
After publishement
To whom data/document is available
Every one
Under which criteria data/document could be used
Without specific roules
From where data/document is obtainable
In addition to correspondence with the website of the magazine that publishes the project article, applicants can send their application to the executive or project manager if needed
What processes are involved for a request to access data/document
Searching the databases of article publishers online After sending the application to the project manager via email or fax number or visiting in person at the mentioned address and confirmed by the project manager, the information will be available to the applicants