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IRCT20190829044642N1 IRCT 2020-08-03 Arak University of Medical Sciences effects of amlodipine to reduce cardiac iron overload The study of the effects of amlodipine addition to combination therapy of Deferiprone and Deferoxamine to reduce cardiac iron overload measurable with T2*MRI in thalassemic patients 2019-09-23 anticipated 30 Complete https://irct.ir/trial/41846 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 30 patients with thalassemia major who are over 5 years old and have received blood regularly for at least 2 years are included in the study. To assign patients to two groups, the block randomization method with the size of four blocks was used. Thus, using online software, the randomization sequence was generated by the block method and remained with the epidemiologist and sought to diagnose and In the first group, 15 patients received amlodipine at a dose of 2.5-5 mg with a chelator, and in the second group, 15 patients received chelator. Will receive alone for one year, Blinding description: This study is a double-blind randomized clinical trial in Amir Kabir hospital in Arak in 1398 with easy sampling. In this study, 30 patients with major thalassemia who are over 5 years old and have been receiving blood for at least 2 years on a regular basis were enrolled after informed consent. Blindness Due to the double blindness of the study means that only the relevant expert in the study is aware of the study type and study groups, while the patients and the statistical experts responsible for analyzing the data are aware. Patients in charge are not aware of the study groups and only identify patients based on groups A and B and complete the checklists accordingly. 3 Major Thalasemia. Intervention 1: Intervention group: Patients will receive amlodipine at a dose of 5 to 2.5 mg with chelator for one year. After one week of treatment with amlodipine, the dose will increase to 5 mg. Intervention 2: Control group: The control group will receive only chelators for one year. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Shima Vakilipour
No. 6, Nastaran 7 Alley, Fatemie Sq., Golestan Town
Tehran Iran (Islamic Republic of) 3759156354 +98 21 5632 5379 sh.vakilipour@arakmu.ac.ir Arak University of Medical Sciences scientific Shima Vakilipour
No. 6, Nastaran 7 Alley, Fatemie Sq., Golestan Town
Tehran Iran (Islamic Republic of) 3848176341 +98 21 5632 5279 sh.vakilipour@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 1. All patients had informed consent to participate in the study. 2- All thalassemia major patients referring to Amir Kabir Hospital, Arak, over 5 years old. .3. All healthy children without any underlying hematologic or hereditary diseases except major thalassemia 5 years no limit Both All patients who did not have informed consent to participate and continue to participate in the study. All patients who will undergo a chelation therapy strategy during the 12 months of study due to changes. All patients with advanced heart failure or Ef less than 30% or AV block All patients with MRI contraindication All patients with liver disorders, hepatitis B and C, HIV, any inflammation and renal failure All patients who have complications with amlodipine include edema, hypotension, palpitations, etc D56.1 Beta thalassemia Treatment - Drugs Placebo Intervention group: Patients will receive amlodipine at a dose of 5 to 2.5 mg with chelator for one year. After one week of treatment with amlodipine, the dose will increase to 5 mg. Control group: The control group will receive only chelators for one year. Cardiac iron overload. Timepoint: Will be measured at baseline and 12 months after treatment. Method of measurement: T2*MRI. Ferritin serum level. Timepoint: At baseline and 1, 6, 12 months after treatment. Method of measurement: ELISA. Arak University of Medical Sciences Approved 2019-02-24 Ethics committee of Arak University of Medical Sciences Shahid shirudi Ave., Alamolhoda St. Arak Markazi Iran (Islamic Republic of)