69089
document
Effect of L-type calcium channel blocker ( amlodipine ) on myocardial iron deposition in patients with thalassaemia with moderate-to-severe myocardial iron deposition : protocol for a randomised , controlled trial . INTRODUCTION Sideroblastic cardiomyopathy secondary to repeated blood transfusions is a feared complication in thalassaemia . Control of myocardial iron is thus becoming the cornerstone of thalassaemia management . Recent evidence suggests a role for L-type Ca ( 2+ ) channels in mediating iron uptake by the heart . Blocking the cellular iron uptake through these channels may add to the benefit of therapy to standard chelation in reducing myocardial iron . We aim to determine the efficacy of amlodipine ( a calcium channel blocker ) as an adjunct to standard aggressive chelation in retarding myocardial iron deposition in thalassaemics with or without cardiomyopathy . OUTCOMES The primary outcome is to compare the efficacy of amlodipine+chelation ( intervention ) versus standard chelation ( control ) in retarding myocardial iron deposition . Secondary outcomes include the effect of amlodipine therapy on systolic and diastolic function , strain and strain rate and liver iron content . METHODS AND ANALYSIS This is a single-centre , parallel-group , prospective randomised control trial . Twenty patients will be randomised in a 1:1 allocation ratio into the intervention and control arms . In addition to conventional echocardiography , MRI T2* values for assessment of cardiac and liver iron load will be obtained at baseline and at 6 and 12 months . Cardiac T2* will be reported as the geometric mean and per cent coefficient of variation , and an increase in cardiac T2* values from baseline will be used as an end point to compare the efficacy of therapy . A p Value of < 0.05 will be considered significant . STUDY SETTING Department of Pediatric and Child Health , Aga Khan University Hospital , Karachi , Pakistan . ETHICS AND DISSEMINATION This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations . Findings will be reported through scientific publications and research conferences and project summary papers for participants . TRIAL REGISTRATION NUMBER ClinicalTrials.Gov . Registration no : NCT02065492 .
69090
Intervention_Pharmacological
amlodipine
69091
Intervention_Pharmacological
amlodipine
69092
Intervention_Pharmacological
amlodipine+chelation
69093
Intervention_Control
standard chelation
69094
Intervention_Pharmacological
amlodipine
69095
Outcome_Physical
myocardial iron deposition
69096
Outcome_Physical
myocardial iron deposition :
69097
Outcome_Physical
repeated blood transfusions
69098
Outcome_Physical
myocardial iron
69099
Outcome_Physical
myocardial iron .
69100
Outcome_Physical
myocardial iron deposition
69101
Outcome_Physical
compare the efficacy of amlodipine+chelation ( intervention ) versus standard chelation ( control ) in retarding myocardial iron deposition .
69102
Outcome_Physical
effect of amlodipine therapy on systolic and diastolic function , strain and strain rate and liver iron content .
69103
Outcome_Physical
cardiac and liver iron load
69104
Participant_Condition
patients with thalassaemia with moderate-to-severe myocardial iron deposition
69105
Participant_Sample-size
Twenty patients
69106
Participant_Condition
Department of Pediatric and Child Health