Table 2.
Primary and secondary endpoints
Mean (SD) baseline, 6-month, and 6-month minus baseline cardiovascular measurements are listed by treatment arm. The treatment effect represents the differences in 6-month minus baseline measurements between groups (i.e. differences of the differences) adjusted for baseline values and age.
| Placebo (n = 8) | Sildenafil (n = 7) | Treatment effect |
p-value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 6- month |
Paired change |
Baseline | 6- month |
Paired change |
[95% CI] | |||
| Primary Outcome | |||||||||
| LV End-systolic Volume | 84.28 (32.92) | 84.09 (30.02) | −0.19 (5.56) | 107.49 (61.66) | 112.69 (79.02) | 5.20 (23.61) | 6.99 [−0.81, 23.77] | 0.379 | |
| Secondary Outcomes | |||||||||
| LV mass | 96.96 (32.67) | 95.91 (26.88) | −1.05 (12.69) | 107.51 (30.09) | 104.11 (29.78) | −3.40 (7.03) | 0.12 [−12.00, 12.23] | 0.983 | |
| LV End-diastolic volume | 152.14 (44.47) | 152.37 (46.19) | 0.24 (8.78) | 178.94 (75.92) | 184.48 (87.36) | 5.54 (18.85) | 6.98 [−8.21, 22.18] | 0.333 | |
| Stroke volume | 67.85 (13.27) | 68.28 (18.88) | 0.43 (11.46) | 71.46 (14.96) | 71.80 (12.17) | 0.34 (9.75) | −0.37 [−14.07, 13.33] | 0.953 | |
| Ejection fraction | 46.14 (7.04) | 45.64 (6.82) | −0.50 (5.24) | 42.64 (8.60) | 43.25 (12.82) | 0.61 (7.00) | −0.60 [−7.98, 6.80] | 0.864 | |
| Forced Vital Capacity1 | 2.32 (1.74) | 2.13 (1.60) | −0.19 (0.21) | 1.70 (0.97) | 1.57 (0.99) | −0.13 (0.09) | 0.01 [0.17, 0.20] | 0.863 | |
| Grasp2 | 8.06 (5.90) | 8.23 (6.21) | 0.17 (1.25) | 8.99 (9.39) | 9.36 (8.78) | 0.37 (0.90) | 0.48 [−0.69, 1.66] | 0.384 | |
| Pinch3 | 3.13 (2.14) | 3.25 (2.27) | 0.12 (0.45) | 2.00 (1.21) | 1.93 (1.11) | −0.06 (0.30) | −0.18 [0.73, 0.37] | 0.478 | |
1
7 placebo, 7 treatment
2
8 placebo, 7 treatment
3
7 placebo, 6 treatment