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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• patients with thalassemia major over 6 years of age in use of iron chelating therapy.

Exclusion Criteria:

• pregnancy;

• advanced heart failure with NYHA III/IV or LVEF < 35%;

• formal contra-indications to an MRI study;

• patient with advanced heart block.