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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250421065432N1

Enrollment

Registered

2026-02-17

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Beta-thalassemia major. Condition 2: Myocardial siderosis. Condition 3: Hepatic iron load. Condition 4: Ferritin serum level. Beta thalassemia major Heart disease, unspecified Other specified diseases of liver Other specified abnormal findings of blood chemistry

Interventions

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 a

Eligibility

Sex/Gender

All

Age

8 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with ß-thalassemia major = 8 years old Increased myocardial iron overload

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamin Alavi

Shahid Beheshti University of Medical Sciences

saminalavi@hotmail.com+98 21 2222 7021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026