Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

Study Overview
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Brief Summary
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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.

Official Title
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Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial

Conditions
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Thalassemia, Iron Overload

Intervention / Treatment
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* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy. No anticipated changes in chelation regimen for the next 12 months Completed and signed Informed Consent Exclusion Criteria: Pregnancy Advanced class III/IV heart failure or LVEF < 0.35% (by MRI) Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc). Advanced heart AV block

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starch pill<br>Placebo | Drug: Amlodipine<br>* 5mg PO initially; may be reduced to 2.5mg PO if side effects<br>* Other names: norvasc;|
| Experimental: Amlodipine<br>Amlodipine 5mg QD | Drug: Amlodipine<br>* 5mg PO initially; may be reduced to 2.5mg PO if side effects<br>* Other names: norvasc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 and 12 months | 
| Serum ferritin levels |  | 6 and 12 months | 
| left ventricle volumes and function |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imaging, Thalassemia, Iron overload