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

• ClinicalTrials.gov Identifier: NCT01125254
• Recruitment Status: Completed
• First Posted: May 18, 2010
• Last Update Posted: January 5, 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: May 13, 2010
• First Posted Date: May 18, 2010
• Last Update Posted Date: January 5, 2015
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2010)

Myocardium T2* [ Time Frame: 12 months ]

Heart T2* by MRI at 12 months

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 17, 2010)

• Liver T2* [ Time Frame: 24 months ]
  Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
• Heart volumes [ Time Frame: 24 months ]
  Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
• Left ventricle ejection fraction [ Time Frame: 24 months ]
  LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
• Serum ferritin [ Time Frame: 24 months ]
  Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
• Myocardium T2* [ Time Frame: 6-18-24 months ]
  Heart T2* by MRI every 6 months until 24 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 Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
• Official Title: Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Thalassemia Major

Intervention

Drug: Amlodipine

5mg po for 12 months

Study Arms

• Experimental: Amlodipine
  amlodipine 5mg qd
  Intervention: Drug: Amlodipine
• Placebo Comparator: Controls
  placebo
  Intervention: Drug: Amlodipine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2010): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 90 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: NCT01125254
• Other Study ID Numbers: 000002
• 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, University of 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; University of Campinas, Brazil

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