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

University of Campinas, Brazil

Status and phase: Completed; Phase 3

Conditions: Thalassemia; Iron Overload

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01395199

AmloThal RCT

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
2. No anticipated changes in chelation regimen for the next 12 months
3. Completed and signed Informed Consent

Exclusion criteria

1. Pregnancy
2. Advanced class III/IV heart failure or LVEF < 0.35% (by MRI)
3. Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
4. Advanced heart AV block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Starch pill

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Amlodipine

Amlodipine

Experimental group

Description:

Amlodipine 5mg QD

Treatment:

Drug: Amlodipine