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IRCT20241013063353N1 IRCT 2025-12-29 Mazandaran University of Medical Sciences Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib Investigation of the effect of carvedilol on cardiac function in patients with chronic myeloid leukemia treated with nilotinib and dasatinib in Sari city 2026-02-20 anticipated 30 Recruiting https://irct.ir/trial/79549 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 chronic myeloid leukemia. Intervention 1: Intervention group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib undergoing carvedilol intervention. Intervention 2: Control group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib without intervention. Yes - There is a plan to make this available What will be shared: All data can be shared When: After publishement To whom: Every one Conditions: Without specific roules Where to obtain: 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 How to obtain: 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 Comments:
public Ali Bazram
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
Sari Iran (Islamic Republic of) 48166234356 +98 11 4204 0905 ali_next@yahoo.com Mazandaran University of Medical Sciences scientific Ramin Shekarriz foumani
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
Sari Iran (Islamic Republic of) 48166234356 +98 11 3336 4044 drraminshekarriz@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with chronic myeloid leukemia treated with nilotinib and dasatinib for at least one year Age>18 Sinus rhythm of the heart 18 years no limit Both 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 C92.1 Chronic myeloid leukemia, BCR/ABL-positive Treatment - Drugs Treatment - Drugs Intervention group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib undergoing carvedilol intervention Control group: Chronic myeloid leukemia patients treated with nilotinib and dasatinib without intervention. 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. Mazandaran University of Medical Sciences Approved 2025-01-23 Ethics committee of Mazandaran university of medical sciences Vice chancellor for research and technology, Moalem Sq, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)