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Completed

NCT Number: NCT01125254

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

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.

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Key information

Conditions

Thalassemia Major Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

6 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Campinas

Campinas, São Paulo, 13100, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine

Drug

5mg po for 12 months

Primary outcomes

  1. Myocardium T2*

    Time frame: 12 months

    Heart T2* by MRI at 12 months

Secondary outcomes

  1. Liver T2*

    Time frame: 24 months

    Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  2. Heart volumes

    Time frame: 24 months

    Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  3. Left ventricle ejection fraction

    Time frame: 24 months

    LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  4. Serum ferritin

    Time frame: 24 months

    Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  5. Myocardium T2*

    Time frame: 6-18-24 months

    Heart T2* by MRI every 6 months until 24 months

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: AnloThal

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 18, 2010
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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