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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Thalassemia Iron Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Starch pill

Placebo

Group Type PLACEBO_COMPARATOR

Amlodipine

Intervention Type DRUG

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

Amlodipine

Amlodipine 5mg QD

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

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

Interventions

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Amlodipine

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

Intervention Type DRUG

Other Intervention Names

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norvasc

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No