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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Campinas, Brazil.
Recruitment status was  Recruiting
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

July 11, 2011
August 25, 2011
August 2011
August 2013   (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
    Intervention: Drug: Amlodipine
  • Experimental: Amlodipine
    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.
 
Recruiting
60
December 2013
August 2013   (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
No
Contact: Juliano L Fernandes, MD, PhD +551935792903 jlaraf@fcm.unicamp.br
Brazil
 
NCT01395199
AmloThal RCT
No
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
August 2011

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