Amlodipine for Myocardial Iron in Thalassemia
Amlodipine for Myocardial Iron in Thalassemia
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.
Null Hypothesis There is no difference between the efficacy of chelation plus amlodipine
 therapy and chelation therapy alone in retarding the rate of myocardial iron deposition in
 thalassemia patients with iron overload and a constant transfusion need.

 Alternate Hypothesis Chelation plus amlodipine therapy is more efficacious than chelation
 therapy alone in retarding the rate of myocardial iron deposition in thalassemia patients
 with iron overload and a constant transfusion need.

 The aim of the investigators study is to determine if amlodipine, an L-type specific calcium
 channel blocker, in addition to the standard aggressive chelation therapy, can retard the
 deposition of iron in the myocardium of thalassemia patients with significant myocardial iron
 load with or without cardiomyopathy.
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.