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

• ClinicalTrials.gov Identifier: NCT01395199
• Recruitment Status: Completed
• First Posted: July 15, 2011
• Last Update Posted: September 9, 2015
• Sponsor: University of Campinas, Brazil
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): Juliano de Lara Fernandes, University of Campinas, Brazil

Tracking Information

• First Submitted Date: July 11, 2011
• First Posted Date: July 15, 2011
• Last Update Posted Date: September 9, 2015
• Study Start Date: August 2012
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2011)

Myocardial T2* values (msec) [ Time Frame: 6 and 12 months ]

T2* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2011)

• Liver T2* values (msec) [ Time Frame: 6 and 12 months ]
  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 ]
• left ventricle volumes and function [ Time Frame: 6 and 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
• Official Title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Thalassemia
• Iron Overload

Intervention

Drug: Amlodipine

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

Other Name: norvasc

Study Arms

• Placebo Comparator: Starch pill
  Placebo
  Intervention: Drug: Amlodipine
• Experimental: Amlodipine
  Amlodipine 5mg QD
  Intervention: Drug: Amlodipine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2015): 62
• Original Estimated Enrollment (submitted: July 14, 2011): 60
• Actual Study Completion Date: February 2015
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01395199
• Other Study ID Numbers: AmloThal RCT
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Juliano de Lara Fernandes, University of Campinas, Brazil
• Original Responsible Party: Juliano de Lara Fernandes, Universidade Estadual de Campinas
• Current Study Sponsor: University of Campinas, Brazil
• Original Study Sponsor: Same as current
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Juliano L Fernandes, MD, PhD; University of Campinas, Brazil

• PRS Account: University of Campinas, Brazil
• Verification Date: September 2015