Table 2 Primary analyses for primary (LV mass) and secondary outcomes
Factor | First Measure | Final Measure | Primary Analysis* |
|---|---|---|---|
LV mass | Baseline | 6 month visit | Comparison of mean change in LV mass for NHD vs control subjects |
Blood pressure | Baseline visit – average of 5 and 10 minute readings | 6 month visit – average of 5 and 10 minute readings | Comparison of mean change in systolic BP for NHD vs control subjects |
Quality of Life | Baseline | 6 month visit | Difference in the 6 month and baseline EQ-5D index scores for NHD vs control group – intention to treat, last observation carried forward |
Anemia | Mean Hct and Epo administered for two months preceding baseline visit | Mean Hct and Epo administered for the final two months of the study | Mean change in hct/epo ratio for NHD vs control subjects |
Mineral Metabolism | Mean Ca*PO4 for two months preceding baseline visit | Mean Ca*PO4 for the final two months of the study | Mean change in Ca*PO4 for NHD vs control subjects |