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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Campinas, Brazil.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01395199
First received: July 11, 2011
Last updated: August 25, 2011
Last verified: August 2011
  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 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 Intervention Phase
Thalassemia
Iron Overload
Drug: Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Myocardial T2* values (msec) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    T2* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance


Secondary Outcome Measures:
  • Liver T2* values (msec) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    T2* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance

  • Serum ferritin levels [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • left ventricle volumes and function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Starch pill Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Name: norvasc
Experimental: Amlodipine Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Name: norvasc

  Eligibility

Ages Eligible for Study:   6 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01395199

Contacts
Contact: Juliano L Fernandes, MD, PhD +551935792903 jlaraf@fcm.unicamp.br

Locations
Brazil
Universidade Estadual de Campinas Recruiting
Campinas, SP, Brazil, 13100000
Contact: Juliano L Fernandes, MD, PhD    +551935792903    jlaraf@fcm.unicamp.br   
Contact    +551937535700      
Principal Investigator: Juliano L Fernandes, MD, PhD         
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Juliano L Fernandes, MD, PhD University of Campinas, Brazil
  More Information

Additional Information:
No publications provided

Responsible Party: Juliano de Lara Fernandes, Physician Researcher, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01395199     History of Changes
Other Study ID Numbers: AmloThal RCT
Study First Received: July 11, 2011
Last Updated: August 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Magnetic resonance imaging
Thalassemia
Iron overload

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

ClinicalTrials.gov processed this record on November 23, 2014