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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125254
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : January 5, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Juliano de Lara Fernandes, University of Campinas, Brazil

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thalassemia Major Drug: Amlodipine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Study Start Date : September 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Amlodipine
amlodipine 5mg qd
 Drug: Amlodipine
5mg po for 12 months
Placebo Comparator: Controls
placebo
 Drug: Amlodipine
5mg po for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Myocardium T2* [ Time Frame: 12 months ]
    Heart T2* by MRI at 12 months


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125254


Locations
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Brazil
University of Campinas
Campinas, SP, Brazil, 13100
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Juliano L Fernandes, MD University of Campinas, Brazil
More Information
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Responsible Party: Juliano de Lara Fernandes, Research Physician, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01125254    
Other Study ID Numbers: 000002
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015
Keywords provided by Juliano de Lara Fernandes, University of Campinas, Brazil:
thalassemia major
calcium channel blockade
magnetic resonance imaging
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
 Metabolic Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents