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

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT01395199

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thalassemia Iron Overload	Drug: Amlodipine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Starch pill Placebo	Drug: Amlodipine 5mg PO initially; may be reduced to 2.5mg PO if side effects Other Names: norvasc
Experimental: Amlodipine Amlodipine 5mg QD	Drug: Amlodipine 5mg PO initially; may be reduced to 2.5mg PO if side effects Other Names: norvasc

Arm

Intervention/Treatment

Placebo Comparator: Starch pill

Placebo

Drug: Amlodipine

5mg PO initially; may be reduced to 2.5mg PO if side effects

Other Names:

norvasc

Experimental: Amlodipine

Amlodipine 5mg QD

Drug: Amlodipine

5mg PO initially; may be reduced to 2.5mg PO if side effects

Other Names:

norvasc

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
No anticipated changes in chelation regimen for the next 12 months
Completed and signed Informed Consent

Exclusion Criteria:

Pregnancy
Advanced class III/IV heart failure or LVEF < 0.35% (by MRI)
Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
Advanced heart AV block