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

Thalassemia Major Clinical Trial

— AnloThal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125254
• Other study ID #: 000002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 13, 2010
• Last updated: January 2, 2015
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Beta-Thalassemia
• Iron Overload
• Thalassemia
• Thalassemia Major

Intervention

Drug:
• Amlodipine
5mg po for 12 months

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardium T2*	Heart T2* by MRI at 12 months	12 months	No
Secondary	Liver T2*	Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.	24 months	No
Secondary	Heart volumes	Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.	24 months	No
Secondary	Left ventricle ejection fraction	LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.	24 months	No
Secondary	Serum ferritin	Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.	24 months	No
Secondary	Myocardium T2*	Heart T2* by MRI every 6 months until 24 months	6-18-24 months	No