The chelation therapy is therefore left to the discretion of the treating haematologist. Since it is a single centre study and the patients are predominantly managed by two haematologists, we have been able to initiate the informal chelation protocol in our study patients, thus introducing standardisation of care. This, along with
our current randomisation selleck chemical process, we hope, will help equally distribute the effect of the chelation in both the arms. On the basis of this reason, we have decided not to randomise on the type of chelation therapy. Blinding While the primary physician and the patients will be aware of the allocated arm, the readers involved in T2* assessment will be blinded to the allocated arm. Similarly, outcome assessors and data analysts will also be blinded to the allocation. Additional measures to ensure data safety and monitoring along with validation will be made, the details
of which will be discussed later in this protocol. Study drug: amlodipine Amlodipine is a long-acting L-type calcium channel blocker that needs to be taken only once a day without any dietary restrictions. Numerous studies have shown that it is better tolerated when compared with other L-type calcium channel blockers like nifedipine.30 It is also available at an easily affordable price that allows maximum compliance and makes the drug highly suitable for our study. Based on the studies available to date, amlodipine should be initiated in children at a dose of 0.05–0.1 mg/kg/day given once daily. Younger children appear to require higher doses, often as much as 0.3–0.4 mg/kg/day. The adult dose is 2.5–5 mg/day.31 The symptomatic adverse reactions produced by amlodipine are tolerable and, if they become severe, can be treated symptomatically; these include abdominal pain, gastrointestinal (GI) disturbance,
blurred vision, headache, Anacetrapib flushing, palpitations, dizziness, somnolence, hypotension and cough. The severe adverse effects of amlodipine, which may give rise to further complications, include peripheral oedema and sinus bradycardia. The contraindications to amlodipine use are hypotension, aortic stenosis and sinoatrial node disease. The paediatric cardiology and haematology team will deal with adverse events (AEs) associated with amlodipine and treatment cost will be covered by the grant budget. The frequency of serious AEs (SAEs) requiring intervention frequency of SAEs requiring intervention is <1%. On this basis, we anticipate at the most one patient who may develop severe AEs requiring interventions like stopping the medication or adding a diuretic.
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