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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: University of Campinas, Brazil

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Serum ferritin levels [ Time Frame: 6 and 12 months ]
  • left ventricle volumes and function [ Time Frame: 6 and 12 months ]


Original Secondary Outcome: Same as current

Information By: University of Campinas, Brazil

Dates:
Date Received: July 11, 2011
Date Started: August 2012
Date Completion:
Last Updated: September 4, 2015
Last Verified: September 2015