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 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
5mg PO initially; may be reduced to 2.5mg PO if side effects
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Myocardial T2* values (msec)
T2\* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance
Time frame: 6 and 12 months
Liver T2* values (msec)
T2\* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance
Time frame: 6 and 12 months
Serum ferritin levels
Time frame: 6 and 12 months
left ventricle volumes and function
Time frame: 6 and 12 months
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