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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starch pill | Placebo Comparator | Placebo |
|
| Amlodipine | Experimental | Amlodipine 5mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | 5mg PO initially; may be reduced to 2.5mg PO if side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum ferritin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliano L Fernandes, MD, PhD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual de Campinas | Campinas | São Paulo | 13100000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37975597 | Derived | 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. | |
| 27412888 | Derived |
| Label | URL |
|---|---|
| Brazilian Thalassemia Association | View source |
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| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 6 and 12 months |
| left ventricle volumes and function | 6 and 12 months |
| 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |