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

This study has been completed.
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: September 4, 2015
Last verified: September 2015

July 11, 2011
September 4, 2015
August 2012
February 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01395199 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Thalassemia
  • Iron Overload
Drug: Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects
Other Name: norvasc
  • Placebo Comparator: Starch pill
    Placebo
    Intervention: Drug: Amlodipine
  • Experimental: Amlodipine
    Amlodipine 5mg QD
    Intervention: Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
6 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01395199
AmloThal RCT
No
Not Provided
Not Provided
Juliano de Lara Fernandes, University of Campinas, Brazil
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Juliano L Fernandes, MD, PhD University of Campinas, Brazil
University of Campinas, Brazil
September 2015

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