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

Summary

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.

Timeline

Start

2012-08

Primary completion

2015-02

Completion

2015-02

Publications

• Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.
• Fernandes JL, Loggetto SR, Verissimo MP, Fertrin KY, Baldanzi GR, Fioravante LA, Tan DM, Higa T, Mashima DA, Piga A, Coelho OR, Costa FF, Saad ST. A randomized trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major. Blood. 2016 Sep 22;128(12):1555-61. doi: 10.1182/blood-2016-06-721183. Epub 2016 Jul 13.

Drugs

Indications