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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01125254
First received: May 13, 2010
Last updated: July 4, 2011
Last verified: May 2010
  Purpose

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 Intervention Phase
Thalassemia Major
Drug: Amlodipine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Myocardium T2* [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Heart T2* by MRI at 12 months


Secondary Outcome Measures:
  • Liver T2* [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  • Heart volumes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  • Left ventricle ejection fraction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  • Serum ferritin [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.

  • Myocardium T2* [ Time Frame: 6-18-24 months ] [ Designated as safety issue: No ]
    Heart T2* by MRI every 6 months until 24 months


Enrollment: 10
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlodipine Drug: Amlodipine
5mg po for 12 months
No Intervention: Controls Drug: Amlodipine
5mg po for 12 months

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125254

Locations
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
  More Information

No publications provided

Responsible Party: Juliano de Lara Fernandes, University of Campinas
ClinicalTrials.gov Identifier: NCT01125254     History of Changes
Other Study ID Numbers: 000002
Study First Received: May 13, 2010
Last Updated: July 4, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Campinas, Brazil:
thalassemia major
calcium channel blockade
magnetic resonance imaging

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 20, 2014