Back to resultsAmlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major (AnloThal)
Primary Purpose
Thalassemia Major
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Thalassemia Major focused on measuring thalassemia major, calcium channel blockade, magnetic resonance imaging
Eligibility 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.
Sites / Locations
- University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amlodipine
Controls
Arm Description
amlodipine 5mg qd
placebo
Outcomes
Primary Outcome Measures
Myocardium T2*
Heart T2* by MRI at 12 months
Secondary Outcome Measures
Liver T2*
Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Heart volumes
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
LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Serum ferritin
Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Myocardium T2*
Heart T2* by MRI every 6 months until 24 months
Full Information
NCT ID
NCT01125254
First Posted
May 13, 2010
Last Updated
January 2, 2015
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01125254
Brief Title
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Acronym
AnloThal
Official Title
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia Major
Keywords
thalassemia major, calcium channel blockade, magnetic resonance imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine
Arm Type
Experimental
Arm Description
amlodipine 5mg qd
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
5mg po for 12 months
Primary Outcome Measure Information:
Title
Myocardium T2*
Description
Heart T2* by MRI at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Liver T2*
Description
Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time Frame
24 months
Title
Heart volumes
Description
Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time Frame
24 months
Title
Left ventricle ejection fraction
Description
LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time Frame
24 months
Title
Serum ferritin
Description
Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Time Frame
24 months
Title
Myocardium T2*
Description
Heart T2* by MRI every 6 months until 24 months
Time Frame
6-18-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliano L Fernandes, MD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13100
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
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