Table 4.
Additional pre-specified endpoints
| Placebo (n=103) | n† | Sildenafil (n=113) | n† | ||
|---|---|---|---|---|---|
| Change in LV structure by CMR at 24 weeks | |||||
| LV mass by CMR, g | 0.6 (−5.7, 7.9)* | 47 | −1.5 (−5.9, 7.1) | 49 | 0.93 |
| LV end-diastolic volume by CMR, ml | −4.3 (−15.5, 8.1) | 47 | 3.7 (−4.9, 14.5) | 49 | 0.13 |
| Change in diastolic function parameters at 24 weeks | |||||
| Medial e′, m/sec | 0.00 (−0.01, 0.01) | 83 | 0.00 (−0.01, 0.01) | 77 | 0.88 |
| E/e′ | −1.6 (−4.7, 2.2) | 80 | 0.2 (−2.4, 3.1) | 75 | 0.16 |
| PA systolic pressure, mmHg | −2 (−8 − 8) | 58 | 2 (−5, 7) | 45 | 0.94 |
| Change in vascular function by CMR at 24 weeks | |||||
| Arterial elastance, mmHg/ml | 0.03 (−0.14, 0.23) | 45 | −0.08 (−0.41, 0.12) | 47 | 0.02 |
| SVR, wood units | 0.13 (−0.15, 0.43) | 45 | −0.04 (−0.38, 0.21) | 47 | 0.09 |
| Aortic distensibility, 10−3mmHg−1 | 0.13 (−0.17, 0.42) | 31 | 0.18 (−0.12, 0.67) | 29 | 0.38 |
| Change in core laboratory biomarkers at 24 weeks | |||||
| Creatinine, mg/dl | 0.01 (−0.10, 0.09) | 94 | 0.05 (−0.04, 0.15) | 94 | 0.047 |
| Cystatin C, mg/L | 0.01 (−0.08, 0.11) | 95 | 0.05 (−0.04, 0.16) | 95 | 0.01 |
| NT-proBNP, pg/ml | −23 (−198, 139) | 94 | 15 (−90, 372) | 95 | 0.03 |
| Endothelin-1, pg/ml | −0.01 (−0.48, 0.47) | 95 | 0.38 (−0.10, 0.97) | 95 | 0.046 |
| Aldosterone, pg/ml | 0 (−70, 48) | 95 | −11 (−77, 30) | 95 | 0.85 |
| NT-procollagen III, ug/L | −0.03 (−1.49, 1.54) | 93 | 0.07 (−1.17, 1.42) | 95 | 0.77 |
| Uric acid, mg/dl | −0.1 (−0.7, 0.7) | 94 | 0.3 (−0.4, 1.4) | 94 | 0.02 |
†
number of patients in placebo or sildenafil groups with data for the variable.
*
results shown as median (IQR)