TABLE 2.
Change from baseline to week 26 and Cohen's d and Cliff's delta statistics for cardiac magnetic resonance imaging (cMRI), right heart catheterisation (RHC) and functional and other non-invasive variables: safety set (n=87)
| n | Baseline | Week 26 |
Change from baseline
to week 26 |
Cohen's d
(95% CL) |
Cliff's delta
(95% CL) |
|
| cMRI variables | ||||||
| RVSV by flow (mL) | 73 | 52.1±17.8 | 64.5±19.4 | 12.3±15.4 | 0.80 (0.55–1.09) | 0.35 (0.20–0.49) |
| RVSV by volume (mL) | 78 | 58.5±20.7 | 68.8±23.7 | 10.3±17.6 | 0.59 (0.36–0.85) | 0.28 (0.12–0.42) |
| RVSVI (mL·m−2) | 73 | 30.0±9.4 | 37.2±9.8 | 7.2±9.0 | 0.80 (0.55–1.09) | 0.45 (0.29–0.58) |
| RVEDV (mL) | 78 | 148.4±47.8 | 140.6±48.6 | −7.8±28.4 | 0.28 (0.05–0.51) | 0.12 (−0.04–0.27) |
| RVESV (mL) | 78 | 90.0±40.9 | 71.8±34.1 | −18.2±23.3 | 0.78 (0.54–1.06) | 0.28 (0.12–0.42) |
| RVEF# (%) | 78 | 41.2±12.8 | 50.3±11.1 | 9.1±9.0 | 1.01 (0.76–1.32) | 0.40 (0.26–0.53) |
| RVCO¶ (mL·min−1) | 72 | 3.8±1.3 | 4.5±1.5 | 0.7±1.1 | 0.65 (0.41–0.92) | 0.30 (0.14–0.45) |
| RVCI¶ (mL·min−1·m−2) | 72 | 2.2±0.7 | 2.6±0.8 | 0.4±0.6 | 0.64 (0.40–0.92) | 0.32 (0.16–0.46) |
| RV mass (g) | 78 | 110.6±46.8 | 99.4±41.4 | −11.3±19.1 | 0.59 (0.36–0.85) | 0.14 (−0.02–0.29) |
| LVSV by flow (mL) | 71 | 47.2±14.8 | 62.1±19.5 | 14.9±13.8 | 1.09 (0.82–1.42) | 0.47 (0.31–0.60) |
| LVSV by volume (mL) | 78 | 54.2±17.6 | 71.0±22.9 | 16.8±15.4 | 1.09 (0.83–1.40) | 0.47 (0.32–0.60) |
| LVSVI (mL·m−2) | 71 | 27.3±7.6 | 36.0±9.8 | 8.7±7.9 | 1.10 (0.84–1.44) | 0.54 (0.38–0.66) |
| LVEDV (mL) | 78 | 86.1±28.2 | 104.5±35.7 | 18.4±21.5 | 0.86 (0.62–1.15) | 0.35 (0.20–0.48) |
| LVESV (mL) | 78 | 31.9±16.0 | 33.6±17.7 | 1.7±10.9 | NTE | NTE |
| LVEF# (%) | 78 | 64.0±10.9 | 68.9±10.1 | 4.9±7.4 | 0.66 (0.43–0.93) | 0.29 (0.13–0.43) |
| LVCO+ (L·min−1) | 70 | 3.5±1.1 | 4.3±1.4 | 0.9±0.9 | 0.92 (0.67–1.24) | 0.42 (0.25–0.56) |
| LVCI+ (L·min−1·m−2) | 70 | 2.0±0.6 | 2.5±0.7 | 0.5±0.6 | 0.91 (0.66–1.23) | 0.44 (0.28–0.58) |
| LV mass (g) | 78 | 103.5±24.3 | 107.3±24.8 | 3.9±9.7 | 0.40 (0.18–0.65) | NTE |
| RVEDV/LVEDV | 78 | 0.5±0.3 | 0.3±0.3 | −0.3±0.3 | 0.93 (0.69–1.23) | 0.45 (0.30–0.57) |
| RVESV/LVESV | 78 | 1.1±0.5 | 0.8±0.4 | −0.3±0.4 | 0.68 (0.45–0.95) | 0.31 (0.16–0.45) |
| RHC variables | ||||||
| PVR (dyn·s·cm−5) | 80 | 984.7±669.1 | 608.5±451.0 | −376.2±404.8 | 0.93 (0.69–1.22) | 0.49 (0.32–0.62) |
| mPAP (mmHg) | 80 | 53.5±15.2 | 44.9±16.2 | −8.6±10.6 | 0.81 (0.58–1.09) | 0.34 (0.16–0.49) |
| mRAP (mmHg) | 79 | 6.8±4.2 | 6.1±3.7 | −0.7±4.1 | NTE | NTE |
| Cardiac index (L·min−1·m−2) | 80 | 2.4±0.7 | 3.0±0.7 | 0.6±0.6 | 0.89 (0.65–1.17) | 0.44 (0.27–0.59) |
| Heart rate (beats·min−1) | 76 | 77.6±13.0 | 73.8±11.7 | −3.7±12.2 | 0.31 (0.08–0.55) | 0.20 (0.01–0.37) |
| Stroke volume (mL) | 76 | 55.7±20.2 | 71.5±19.7 | 15.8±18.6 | 0.85 (0.61–1.14) | 0.46 (0.29–0.61) |
| Functional and other non-invasive variables | ||||||
| 6MWD (m) | 83 | 405.3±116.7 | 448.7±110.6 | 43.3±73.5 | 0.59 (0.37–0.84) | 0.27 (0.12–0.41) |
| Absolute NT-proBNP (ng·L−1) | 72 | 1172.8±1824.0 | 481.7±879.4 | −691.1±1612.8 | 0.43 (0.20–0.69) | 0.37 (0.22–0.51) |
| Log-transformed NT-proBNP (ng·L−1) | 72 | 6.3±1.3 | 5.4±1.1 | −0.9±0.9 | 1.01 (0.77–1.24) | 0.37 (0.22–0.51) |
| Borg dyspnoea score | 80 | 3.9±2.1 | 3.1±2.0 | −0.8±2.3 | 0.34 (0.12–0.58) | 0.18 (0.02–0.33) |
| DBP (mmHg) | 83 | 73.8±11.5 | 69.9±11.0 | −3.9±9.7 | 0.40 (0.18–0.64) | 0.18 (0.03–0.33) |
| SBP (mmHg) | 83 | 116.0±14.0 | 115.6±14.8 | −0.3±14.7 | NTE | NTE |
| Heart rate (beats·min−1) | 83 | 80.1±12.9 | 76.2±13.2 | −3.9±13.4 | 0.29 (0.07–0.52) | 0.19 (0.03–0.33) |
Baseline, week 26 and change from baseline to week 26 data are presented as mean±sd. #: determined from standard volumetric measurements; ¶: determined from pulmonary artery flow; +: determined from aortic flow. Due to rounding, in some cases the difference between week 26 and baseline values does not equate to the change in baseline value. For the standardised treatment effect sizes: dark blue indicates a large change, mid-blue indicates a medium change and light blue indicates a small/fair change; NTE indicates no treatment effect (Cohen's d <0.20; Cliff's delta <0.11). CL: confidence limit; RV: right ventricular; RVSV: RV stroke volume; RVSVI: RVSV index; RVEDV: RV end-diastolic volume; RVESV: RV end-systolic volume; RVEF: RV ejection fraction; RVCO: RV cardiac output; RVCI: RV cardiac index; LV: left ventricular; LVSV: LV stroke volume; LVSVI: LVSV index; LVEDV: LV end-diastolic volume; LVESV: LV end-systolic volume; LVEF: LV ejection fraction; LVCO: LV cardiac output; LVCI: LV cardiac index; RHC: right heart catheterisation; PVR: pulmonary vascular resistance; mPAP: mean pulmonary arterial pressure; mRAP: mean right arterial pressure; 6MWD: 6-min walk distance; NT-proBNP: N-terminal pro-brain natriuretic peptide; DBP: diastolic blood pressure; SBP: systolic blood pressure.