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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01395199

Acronym

AmloThal

Enrollment

Registered

2011-07-15

Start date

2012-08-31

Completion date

2015-02-28

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Overload, Thalassemia

Keywords

Magnetic resonance imaging, Thalassemia, Iron overload

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.

Interventions

DRUGAmlodipine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026