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

Primary Purpose

Thalassemia, Iron Overload

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thalassemia focused on measuring Magnetic resonance imaging, Thalassemia, Iron overload

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Estadual de Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Starch pill

Amlodipine

Arm Description

Placebo

Amlodipine 5mg QD

Outcomes

Primary Outcome Measures

Myocardial T2* values (msec)
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)
T2* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance
Serum ferritin levels
left ventricle volumes and function

Full Information

First Posted
July 11, 2011
Last Updated
September 4, 2015
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01395199
Brief Title
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Acronym
AmloThal
Official Title
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia, Iron Overload
Keywords
Magnetic resonance imaging, Thalassemia, Iron overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starch pill
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Amlodipine
Arm Type
Experimental
Arm Description
Amlodipine 5mg QD
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
norvasc
Intervention Description
5mg PO initially; may be reduced to 2.5mg PO if side effects
Primary Outcome Measure Information:
Title
Myocardial T2* values (msec)
Description
T2* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Liver T2* values (msec)
Description
T2* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance
Time Frame
6 and 12 months
Title
Serum ferritin levels
Time Frame
6 and 12 months
Title
left ventricle volumes and function
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy. No anticipated changes in chelation regimen for the next 12 months Completed and signed Informed Consent Exclusion Criteria: Pregnancy Advanced class III/IV heart failure or LVEF < 0.35% (by MRI) Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc). Advanced heart AV block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliano L Fernandes, MD, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual de Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13100000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27412888
Citation
Fernandes JL, Loggetto SR, Verissimo MP, Fertrin KY, Baldanzi GR, Fioravante LA, Tan DM, Higa T, Mashima DA, Piga A, Coelho OR, Costa FF, Saad ST. A randomized trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major. Blood. 2016 Sep 22;128(12):1555-61. doi: 10.1182/blood-2016-06-721183. Epub 2016 Jul 13.
Results Reference
derived
Links:
URL
http://www.abrasta.org.br/
Description
Brazilian Thalassemia Association

Learn more about this trial

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

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