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

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ClinicalTrials.gov Identifier: NCT01395199
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : September 9, 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 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.

Condition or disease Intervention/treatment Phase
Thalassemia Iron Overload Drug: Amlodipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
Study Start Date : August 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Starch pill
Placebo
 Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Name: norvasc
Experimental: Amlodipine
Amlodipine 5mg QD
 Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Name: norvasc


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
  2. No anticipated changes in chelation regimen for the next 12 months
  3. Completed and signed Informed Consent

Exclusion Criteria:

  1. Pregnancy
  2. Advanced class III/IV heart failure or LVEF < 0.35% (by MRI)
  3. Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
  4. Advanced heart AV 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): NCT01395199


Locations
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Brazil
Universidade Estadual de Campinas
Campinas, SP, Brazil, 13100000
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, PhD University of Campinas, Brazil
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juliano de Lara Fernandes, Physician Researcher, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01395199    
Other Study ID Numbers: AmloThal RCT
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Juliano de Lara Fernandes, University of Campinas, Brazil:
Magnetic resonance imaging
Thalassemia
Iron overload
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