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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.