Table 3. Summary of pivotal study MRI data by dose group.
MRI Index | Treatment | Baseline (t = 8 wk) | Endpoint (t = 16 wk) | Paired t-test p value |
Scar mass (g) | Placebo | 6.1±1.9 | 7.2±2.4 | <0.001 |
CSps | 6.7±3.1 | 6.4±2.6 | ns | |
Scar size (% of LV) | Placebo | 10.9±2.3 | 11.5±2.4 | 0.026 |
CSps | 11.1±3.2 | 9.5±2.7 | <0.001 | |
Viable myocardium (g) | Placebo | 50.0±6.3 | 54.7±6.5 | <0.001 |
CSps | 51.9±6.8 | 60.0±6.9 | <0.001 | |
LV mass (g) | Placebo | 56.1±7.6 | 61.9±8.1 | <0.001 |
CSps | 58.6±9.2 | 66.4±8.9 | <0.001 | |
LVEF (%) | Placebo | 42.1±7.0 | 40.9±7.7 | ns |
CSps | 43.6±5.2 | 43.2±5.1 | ns | |
EDV (ml) | Placebo | 80.8±21.7 | 93.2±20.1 | 0.001 |
CSps | 81.7±15.5 | 89.0±23.5 | ns | |
ESV (ml) | Placebo | 48.0±18.3 | 56.3±19.3 | 0.002 |
CSps | 46.7±13.6 | 51.5±19.7 | Ns | |
Body weight gain (kg) | Placebo | n/a | +12.5±3.8 | ns (Ind t-test) |
CSps | n/a | +14.0±4.7 | ||
HR during MRI (bpm) | Placebo | n/a | 112±13 | ns (Ind-t-test) |
CSps | n/a | 99±18 |