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

University of Campinas, Brazil

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thalassemia Major

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01125254

000002

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 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.

Enrollment: 10 patients

Sex: All

Ages: 6 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Amlodipine

Experimental group

Description:

amlodipine 5mg qd

Treatment:

Drug: Amlodipine

Controls

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Amlodipine