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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125254

Acronym

AnloThal

Enrollment

Registered

2010-05-18

Start date

2008-09-30

Completion date

2011-07-31

Last updated

2015-01-05

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

Conditions

Thalassemia Major

Keywords

thalassemia major, calcium channel blockade, magnetic resonance imaging

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.

Interventions

DRUGAmlodipine

5mg po for 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Myocardium T2*	12 months	Heart T2\* by MRI at 12 months

Secondary

Measure	Time frame	Description
Liver T2*	24 months	Liver T2\* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
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.
Left ventricle ejection fraction	24 months	LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Serum ferritin	24 months	Serum ferritin 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026