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NCT Number: NCT01395199

Amlodipine 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 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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Estadual de Campinas

Campinas, São Paulo, 13100000, 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 with at least 6 years of age undergoing iron chelation therapy.
  • No anticipated changes in chelation regimen for the next 12 months
  • Completed and signed Informed Consent

Exclusion criteria

  • Pregnancy
  • Advanced class III/IV heart failure or LVEF < 0.35% (by MRI)
  • Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
  • Advanced heart AV block

Treatment and study plan

Amlodipine

Drug

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

Other names: norvasc

Primary outcomes

  1. Myocardial T2* values (msec)

    Time frame: 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 outcomes

  1. Liver T2* values (msec)

    Time frame: 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

  2. Serum ferritin levels

    Time frame: 6 and 12 months

  3. left ventricle volumes and function

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: AmloThal

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2011
Registry last updated
Sep 9, 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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