Data collection: Data will be collected
using abstraction forms. Adverse effects will also be collected using the AE form. These forms and data spreadsheets will be kept under lock and key. The computer library will be password protected. Any serious adverse effects our website associated with amlodipine and its use will be reported to the ERC and granting agency by the CTU and PI. amlodipine to the Ethics Review Committee (ERC) and granting agency will be the responsibility of the CTU and PI. These events will also be monitored by the Data Safety and Monitoring Board (DSMB). Statistical analysis Outcome variables Our primary outcome is T2* values, which we will measure in milliseconds. A T2* recording will be taken at the initial visit, at 6 months and at 12 months. Secondary outcomes will be looking at differences in absolute LV size, EF, strain and strain rate, diastolic function as mentioned earlier. We will also look at the liver iron content and rate of deposition
in the liver. Data will be entered in SPSS V.19. Continuous parameters will be presented as the mean with SD. However, since T2* is not normally distributed, we will report T2* as the geometric mean (antilog of the mean of the log data) and per cent coefficient of variation (CV—equivalent to the variance of the mean in log scale) following log transformation of data. Mann Whitney U or Wilcoxon sign-rank test will be used for testing of continuous variables. Fisher exact or χ2 test will be used for categorical variables. A p value of <0.05 will be used as significance. T2* calculations will
be performed by two independent observers on 10 studies to account for interobserver variability. At least 10 out of all the 60 potential T2* cardiac MRIs and calculations (baseline and two follow-up visits included) will be sent to an international centre for validation. Similarly, Carfilzomib myocardial strain analysis will also be performed by two observers on 10 studies to determine interobserver variability. One of the observers will recalculate the strain and strain rate on 10 studies after a week of the original measurements to help determine intraobserver variability. Following completion of imaging at 6 months, an interim analysis will be performed. To ensure proper conduct of the study along with the safety of participants and the validity and integrity of the data, all demographical and working details as well as data and statistical analysis will be reviewed by an independent DSMB.