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

Phase 3

Completed

• Conditions: Thalassemia; Iron Overload
• Interventions: Drug: Amlodipine

• Registration Number: NCT01395199
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Study Start: 2012-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine	Amlodipine	Amlodipine 5mg QD
Starch pill	Amlodipine	Placebo

Primary Outcome Measures

Name	Time	Method
Myocardial T2* values (msec)	6 and 12 months	T2\* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance

Secondary Outcome Measures

Name	Time	Method
Liver T2* values (msec)	6 and 12 months	T2\* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance
Serum ferritin levels	6 and 12 months
left ventricle volumes and function	6 and 12 months

Trial Locations

Locations (1)

Universidade Estadual de Campinas; 🇧🇷 Campinas, SP, Brazil