Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin H.M. Kuo, MD, MSc, FRCPC
• Treatments: Amlodipine; Calcium Channel Blockers; Deferasirox; Iron

Criteria

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 to amlodipine or other dihydropyridines