Amlodipine for Myocardial Iron in Thalassemia (NCT02065492) | Clinical Trial Compass
CompletedPhase 2/3
Amlodipine for Myocardial Iron in Thalassemia
Pakistan20 participantsStarted 2014-02
Plain-language summary
Children with thalassemia may have high iron levels after receiving blood transfusions. These high iron levels can have damaging effects on the body, especially the heart. Conventionally only chelation therapy was given for prevention of iron buildup in the heart. However, current research has shown that another drug, amlodipine, also helps to slow down the deposition of iron in the heart. This study is designed to see if patients receiving amlodipine along with their regular chelation therapy have a slower rate of iron buildup in the heart when compared with patients who are receiving chelation only.
Who can participate
Age range
6 Years – 20 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:
* Pediatric patients aged ≥ 6 and ≤ 20 years managed at AKUH for at least 1 year
* ≥ 10 blood transfusion in life time
* Transfusion need ≥ 180 ml/kg/year
* Serum ferritin ≥ 1000 ug/dl
* Patient deemed capable of receiving chelation therapy (by treating hematologist) either subcutaneous infusion of Deferoxamine (Desferal) (3-5 days a week) or oral deferasirox (daily) or Defeperione (oral) or a combination of Desferal and Defeperione.
* Patients who have been on a stable chelation regimen ≥ 6 months
* Completed and signed Informed consent/assent.
Exclusion Criteria:
* Patients with known hypersensitivity to amlodipine.
* Patients with known sinoatrial nodal disease or aortic stenosis.
* Patients with known severe myocardial dysfunction, defined as A LV ejection fraction of ≤ 4 SD for age even without symptoms.
* Patients with known signs and symptoms of heart failure.
* Patients with a T2\* value of \< 4 ms on cardiac MRI.
* Patients with systolic blood pressures ≤ 2 SD for age (systemic hypotension) at the time of enrolment.
* Patients with previously diagnosed significant congenital heart diseases or acquired heart diseases other than thalassemia (as defined earlier).
* Patients with known contraindications to MRI (pacemakers, cerebral aneurysm metal clips, etc.)
* Patient with a known history of developing tetany after use of a calcium channel blocker
* Known pregnancy.
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.
What they're measuring
1
Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times)
Timeframe: At baseline, and then at 6 months and 12 months from the start of the study