This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
5mg po for 12 months
University of Campinas
Campinas, São Paulo, Brazil
Myocardium T2*
Heart T2\* by MRI at 12 months
Time frame: 12 months
Liver T2*
Liver T2\* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time frame: 24 months
Heart volumes
Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time frame: 24 months
Left ventricle ejection fraction
LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time frame: 24 months
Serum ferritin
Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time frame: 24 months
Myocardium T2*
Heart T2\* by MRI every 6 months until 24 months
Time frame: 6-18-24 months
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