Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Tha… (NCT02474420) | Clinical Trial Compass
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Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients
Canada60 participantsStarted 2015-06
Plain-language summary
This is a randomized, open label, two arms superiority trial of a representative population of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of moderate cardiac iron overload, defined as an average T2\* MRI parameter at the mid inter-ventricular septum between 10 and 20ms.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of transfusion-dependent Thalassemia being followed by a thalassemia comprehensive care clinic Age 18 or older
* Taking deferasirox and on a stable dose for \>3 months
* Evidence on cardiac MRI of mild to moderate cardiac iron overload (T2\*\<20ms but ≥10ms) as measured within 3 months prior to randomization. If a recent cardiac MRI has not been obtained, patients who otherwise meet all eligibility criteria and provide appropriate consent will undergo a cardiac MRI to confirm eligibility
* Preserved left ventricular ejection fraction (LVEF) \>55% as measured by cardiac MRI. If a recent cardiac MRI has not been obtained, patients who otherwise meet all eligibility criteria and provide appropriate consent will undergo a cardiac MRI to confirm eligibility.
* Agreeable to use an approved method of contraception if female of childbearing potential for the entire duration of the study.
Exclusion Criteria:
* Serum ferritin \< 500 ng/mL at screening
* Liver iron concentration \> 30 mg/g dw as measured by liver R2 MRI (FerriScan)
* Congestive heart failure
* Severe refractory Hypotension (less than 90 mmHg systolic)
* Currently taking any calcium channel blockers
* Pregnancy or nursing (a negative HCG (pregnancy) test must be obtained prior to randomization)
* As a result of medical review, physical examination or screening investigations, the Principal Investigator (PI) considers the subject unfit for the study
* No fixed address
* Hypersensitivity …