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

Thalassemia Clinical Trial

— AmloThal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395199
• Other study ID #: AmloThal RCT
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2011
• Last updated: September 4, 2015
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Beta-Thalassemia
• Iron Overload
• Thalassemia

Intervention

Drug:
• Amlodipine
5mg PO initially; may be reduced to 2.5mg PO if side effects

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Campinas	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial T2* values (msec)	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	No
Secondary	Liver T2* values (msec)	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	No
Secondary	Serum ferritin levels		6 and 12 months	No
Secondary	left ventricle volumes and function		6 and 12 months	No

External Links

•   Brazilian Thalassemia Association