NCT01125254

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 6 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thalassemia Major

Interventions

Type	Name	Description
DRUG	Amlodipine	5mg po for 12 months

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-05-18
• Last updated: 2015-01-05

Locations

1 site across 1 country: Brazil