NCT01395199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

July 11, 2011

Last Update Submit

September 4, 2015

Conditions

ThalassemiaIron Overload

Keywords

Magnetic resonance imagingThalassemiaIron overload

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Liver T2* values (msec)

    6 and 12 months

  • Serum ferritin levels

    6 and 12 months

  • left ventricle volumes and function

    6 and 12 months

Study Arms (2)

Starch pill

PLACEBO COMPARATOR

Placebo

Drug: Amlodipine

Amlodipine

EXPERIMENTAL

Amlodipine 5mg QD

Drug: Amlodipine

Interventions

AmlodipineDRUG

5mg PO initially; may be reduced to 2.5mg PO if side effects

Also known as: norvasc
AmlodipineStarch pill

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
  • No anticipated changes in chelation regimen for the next 12 months
  • Completed and signed Informed Consent

You may not qualify if:

  • Pregnancy
  • Advanced class III/IV heart failure or LVEF \< 0.35% (by MRI)
  • Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
  • Advanced heart AV block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual de Campinas

Campinas, São Paulo, 13100000, Brazil

Location

Related Publications (2)

  • 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: 37975597DERIVED

  • Fernandes JL, Loggetto SR, Verissimo MP, Fertrin KY, Baldanzi GR, Fioravante LA, Tan DM, Higa T, Mashima DA, Piga A, Coelho OR, Costa FF, Saad ST. A randomized trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major. Blood. 2016 Sep 22;128(12):1555-61. doi: 10.1182/blood-2016-06-721183. Epub 2016 Jul 13.

    PMID: 27412888DERIVED

Related Links

MeSH Terms

Conditions

ThalassemiaIron Overload

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Juliano L Fernandes, MD, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Researcher

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 15, 2011

Study Start

August 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

BR(1)