Hasan 2014.

Trial name or title	Effect of L‐type calcium channel blocker (amlodipine) on myocardial iron deposition in patients with thalassaemia with moderate‐to‐severe myocardial iron deposition.
Methods	Randomised controlled trial (open label, single blinded). Design: parallel group. Duration: 12 months. Location: single centre, a tertiary care hospital in Pakistan.
Participants	Inclusion criteria: age ≥ 6 and ≤ 20 years, ≥ 10 blood transfusions in a lifetime, transfusion need ≥180 mL/kg/year, serum ferritin ≥1000 μg/dL, deemed eligible for standard chelation therapy (by treating haematologist), individuals who have been on a stable chelation regimen for ≥6 months. Exclusion criteria: known hypersensitivity to amlodipine or history of developing tetany after use of a calcium channel blocker, known sinoatrial nodal disease or aortic stenosis, known severe myocardial dysfunction (LVEF of ≤4 SD for age even without symptoms), signs and symptoms of heart. failure, T2* value of <4 m/s on cardiac MRI, systolic blood pressure ≤2 SD for age (systemic hypotension) at the time of enrolment, previously diagnosed significant congenital heart diseases or acquired heart diseases other than thalassaemia, known contraindications to MRI, known pregnancy. Total cohort N = 21, 62 % male. Intervention group n =10, median age 18.0 years (IQR 15.8 ‐ 19.3), 50 % male. Control group n = 11, median age 16.0 years (IQR 13.0 ‐ 18.0), 73% male.
Interventions	Intervention group: oral amlodipine 10 mg once daily in addition to standard chelation therapy. Control group: standard chelation therapy alone.
Outcomes	Primary outcome: difference in heart T2* values (m/s) between groups at 12 months. Secondary outcomes: effects on systolic and diastolic function, absolute left ventricular size, ejection fraction, strain and strain rate, echocardiographic assessment of diastolic function, MRI evaluation of liver iron content by T2*.
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Notes	Completed November 2015; awaiting peer review and publication.