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

September 4, 2015 updated by: Juliano de Lara Fernandes, University of Campinas, Brazil

Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 13100000
        • Universidade Estadual De Campinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Starch pill
Placebo
Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Names:
  • norvasc
Experimental: Amlodipine
Amlodipine 5mg QD
Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Names:
  • norvasc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial T2* values (msec)
Time Frame: 6 and 12 months
T2* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver T2* values (msec)
Time Frame: 6 and 12 months
T2* values represent the amount of iron in the liver and is quantified in msec and measured by cardiovascular magnetic resonance
6 and 12 months
Serum ferritin levels
Time Frame: 6 and 12 months
6 and 12 months
left ventricle volumes and function
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Juliano L Fernandes, MD, PhD, University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AmloThal RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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