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

This study is currently recruiting participants.

Verified August 2011 by University of Campinas, Brazil

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2011

Last Updated Date

August 25, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01395199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Thalassemia
Iron Overload

Intervention ^ICMJE

Drug: Amlodipine

5mg PO initially; may be reduced to 2.5mg PO if side effects

Other Name: norvasc

Study Arm (s)

Placebo Comparator: Starch pill
Intervention: Drug: Amlodipine
Experimental: Amlodipine
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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Juliano L Fernandes, MD, PhD

+551935792903

jlaraf@fcm.unicamp.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01395199

Other Study ID Numbers ^ICMJE

AmloThal RCT

Has Data Monitoring Committee

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, PhD

University of Campinas, Brazil

Information Provided By

University of Campinas, Brazil

Verification Date

August 2011

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

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