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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01125254
Other study ID # 000002
Secondary ID
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


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
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