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

Phase 2

Completed

• Conditions: Thalassemia Major
• Interventions: Drug: Amlodipine

• Registration Number: NCT01125254
• Lead Sponsor: University of Campinas, Brazil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-02
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Controls	Amlodipine	placebo
Amlodipine	Amlodipine	amlodipine 5mg qd

Primary Outcome Measures

Name	Time	Method
Myocardium T2*	12 months	Heart T2\* by MRI at 12 months

Secondary Outcome Measures

Name	Time	Method
Serum ferritin	24 months	Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Liver T2*	24 months	Liver T2\* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Left ventricle ejection fraction	24 months	LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Myocardium T2*	6-18-24 months	Heart T2\* by MRI every 6 months until 24 months
Heart volumes	24 months	Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

Trial Locations

Locations (1)

University of Campinas; 🇧🇷 Campinas, SP, Brazil