Overview
Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients
Status:
Unknown status
Unknown status
Trial end date:
2018-06-01
2018-06-01
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kevin H.M. Kuo, MD, MSc, FRCPCTreatments:
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