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

NCT01125254 | Completed Phase 2

• 1 other identifier: 000002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI.

Conditions

Thalassemia Major

Keywords

thalassemia major; calcium channel blockade; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Myocardium T2*

  Heart T2\* by MRI at 12 months

  12 months

Secondary Outcomes (5)

• Liver T2*

  24 months

• Heart volumes

  24 months

• Left ventricle ejection fraction

  24 months

• Serum ferritin

  24 months

• Myocardium T2*

  6-18-24 months

Study Arms (2)

Amlodipine

EXPERIMENTAL

amlodipine 5mg qd

Drug: Amlodipine

Controls

PLACEBO COMPARATOR

placebo

Drug: Amlodipine

Interventions

Amlodipine DRUG

5mg po for 12 months

Amlodipine; Controls

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with thalassemia major over 6 years of age in use of iron chelating therapy.

You may not qualify if:

• pregnancy;
• advanced heart failure with NYHA III/IV or LVEF \< 35%;
• formal contra-indications to an MRI study;
• patient with advanced heart block.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13100, Brazil

Location

Related Publications (1)

• Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.

  PMID: 37975597 DERIVED

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Juliano L Fernandes, MD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physician

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 18, 2010
• Study Start: September 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

BR (1)