Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02474420
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02474420
Study Brief:
Protocol Section:
NCT02474420