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

• Status: Completed
• Trial end date: 2015-02-01
• 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 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.

• Phase: 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:

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