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IRCT20250421065432N1 IRCT 2026-02-17 Shahid Beheshti University of Medical Sciences Oral Amlodipine and Cardiac Iron load in Beta-Thalassemia Major Investigation of the effect of oral amlodipine on cardiac and liver iron load and echocardiographic indices in patients with beta-thalassemia major 2026-02-20 anticipated 50 Recruiting https://irct.ir/trial/83121 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be a randomized, parallel-group, double-blind, placebo-controlled, multicenter clinical trial. Based on the determined sample size, 50 patients will be allocated in a 1:1 ratio to either the intervention or control group. Randomization will be performed using permuted block randomization with a block size of 4 to ensure balanced allocation between the groups. Each patient will be considered an independent unit. The randomization sequence will be generated using the online statistical service sealedenvelope.com. To ensure allocation concealment, the sequence will be placed in sequentially numbered, sealed, opaque envelopes. The enrolling investigators will be blinded to group assignment, and an envelope will only be opened after a patient is formally enrolled, Blinding description: The active drug and placebo will be manufactured as tablets identical in appearance, size, color, odor, and packaging by a pharmacotherapy specialist at Mofid Children's Hospital. Medication packages will be labeled only with a unique patient identification code and stored in the central research pharmacy. After eligibility is confirmed and informed consent is obtained, each enrolled patient will be sequentially assigned an identification code. The pharmacy will then dispense the corresponding monthly medication package. All paraclinical assessments will be performed by trained technicians and physicians who are blinded to the patient's treatment assignment. Following the completion of the 12-month treatment period and data collection, a blinded statistician will conduct the preliminary analysis using coded groups (A and B). After review and approval by the monitoring committee, the sealed envelopes containing the allocation codes will be opened by an independent, blinded party (the research manager) to reveal the actual group assignments for the final analysis. Finally, participants and research staff will be asked to guess the assigned treatment group to assess the success of blinding. 3 Condition 1: Beta-thalassemia major. Condition 2: Myocardial siderosis. Condition 3: Hepatic iron load. Condition 4: Ferritin serum level. Intervention 1: Intervention group:Patients in the intervention group will receive one oral tablet of amlodipine daily for a period of 12 months. The dosage will be 5 mg for patients weighing ≥30 kg and 2.5 mg for patients weighing <30 kg. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification. Intervention 2: Control group:Patients in the control group will receive one oral placebo tablet daily for a period of 12 months. The placebo will be identical to amlodipine in terms of appearance, color, packaging, and taste, with the only difference being the absence of the active ingredient. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to privacy, we do not plan for sharing the other data.
public Samin Alavi
Pediatric Hematology and Oncology Research Center, Mofid Children’s Hospital, Shariati Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 15514-15468 +98 21 2222 7021 saminalavi@hotmail.com Shahid Beheshti University of Medical Sciences scientific Samin Alavi
Pediatric Hematology and Oncology Research Center, Mofid Children’s Hospital, Shariati Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 15514-15468 +98 21 2222 7021 saminalavi@hotmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with β-thalassemia major ≥ 8 years old Increased myocardial iron overload 8 years no limit Both Known hypersensitivity or allergy to amlodipine Unwillingness to take the study medication Unwillingness to participate in the study Inability or unwillingness to follow study instructions (poor compliance) D56.1 I51.9 K76.89 R79.89 Beta thalassemia major Heart disease, unspecified Other specified diseases of liver Other specified abnormal findings of blood chemistry Treatment - Drugs Placebo Intervention group:Patients in the intervention group will receive one oral tablet of amlodipine daily for a period of 12 months. The dosage will be 5 mg for patients weighing ≥30 kg and 2.5 mg for patients weighing <30 kg. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification. Control group:Patients in the control group will receive one oral placebo tablet daily for a period of 12 months. The placebo will be identical to amlodipine in terms of appearance, color, packaging, and taste, with the only difference being the absence of the active ingredient. The tablets will be manufactured by Rooz Darou Pharmaceutical Company and administered orally. The patients’ standard iron chelation regimen will be continued without any modification. Cardiac iron measured by MRI-T2*. Timepoint: Myocardial iron deposition is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: cardiac MRI (T2*- MRI). Left ventricular ejection fraction measured by echocardiography. Timepoint: Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: echocardiography. Hepatic iron load measured by MRI. Timepoint: Hepatic iron deposition is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: liver MRI. Serum ferritin level. Timepoint: Serum ferritin level is measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: ELISA. Left ventricular end-diastolic volume measured by echocardiography. Timepoint: Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: echocardiography. Left ventricular end-systolic volume measured by echocardiography. Timepoint: Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: echocardiography. Early (E) to late (A) ventricular filling velocities (E/A ratio) measured by echocardiography. Timepoint: Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: echocardiography. Mitral annular velocity (e’) measured by echocardiography. Timepoint: Cardiac indices are measured at the baseline (before the intervention) and 12 months after the administration of amlodipine. Method of measurement: echocardiography. Shahid Beheshti University of Medical Sciences Approved 2024-10-08 Ethics Committee, School of Medicine, Shahid Beheshti University of Medical Sciences Ethics Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Yemen St., Shahid Arabi St., Next to Ayatollah Taleghani Hospital, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)