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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

Tracking Information
First Submitted Date  ICMJE May 13, 2010
First Posted Date  ICMJE May 18, 2010
Last Update Posted Date January 5, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
Myocardium T2* [ Time Frame: 12 months ]
Heart T2* by MRI at 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01125254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • 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.
  • 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.
  • 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.
  • Serum ferritin [ Time Frame: 24 months ]
    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 ]
    Heart T2* by MRI every 6 months until 24 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Official Title  ICMJE Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia Major
Intervention  ICMJE Drug: Amlodipine
5mg po for 12 months
Study Arms  ICMJE
  • Experimental: Amlodipine
    amlodipine 5mg qd
    Intervention: Drug: Amlodipine
  • Placebo Comparator: Controls
    placebo
    Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2010)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01125254
Other Study ID Numbers  ICMJE 000002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juliano de Lara Fernandes, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Juliano L Fernandes, MD University of Campinas, Brazil
PRS Account University of Campinas, Brazil
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP