Table 1.
Baseline demographic, hemodynamic, and biochemical characteristics of the study population available for analysis at the 12‐month timepoint
| Placebo | Tadalafil | ||||
|---|---|---|---|---|---|
| N | Result | N | Result | p value | |
| Age (year) | 9 | 66 ± 8.5 | 15 | 69 ± 5.9 | 0.37 |
| Caucasian race | 9 | 8 (89) | 15 | 14 (93) | 1.00 |
| BMI (kg/m2) | 9 | 28.1 (25.0–33.2) | 15 | 30.4 (27.0–31.4) | 0.65 |
| BMI category | 9 | 15 | 0.63 | ||
| Normal (<25) | 2 (22) | 2 (13) | |||
| Overweight (25–30) | 4 (44) | 5 (33) | |||
| Obese (≥30) | 3 (33) | 8 (53) | |||
| 6MWD (m) | 9 | 297 (210–332) | 15 | 254 (174–319) | 0.77 |
| Pulmonary function | |||||
| FEV1 (L) | 9 | 1.6 ± 0.9 | 15 | 1.7 ± 0.5 | 0.70 |
| %‐Predicted FEV1 | 9 | 50 ± 32 | 15 | 52 ± 21 | 0.84 |
| FVC (L) | 9 | 3.2 ± 0.9 | 15 | 3.1 ± 0.7 | 0.81 |
| %‐Predicted FVC | 9 | 75 ± 25 | 15 | 72 ± 25 | 0.71 |
| FEV1/FVC | 9 | 0.45 ± 0.17 | 15 | 0.53 ± 0.08 | 0.25 |
| DLCO (% predicted) | 6 | 36 (24–53) | 15 | 35 (28–46) | 0.79 |
| SaO2 (%) | 9 | 96 (93–97) | 15 | 94 (93–96) | 0.43 |
| Hemodynamics | |||||
| Heart rate (bpm) | 9 | 87 (69–96) | 14 | 71 (61–86) | 0.07 |
| SBp (mmHg) | 9 | 125 (118–140) | 14 | 136 (109–149) | 0.89 |
| DBp (mmHg) | 9 | 80 (71–86) | 14 | 71 (68–83) | 0.43 |
| Systolic PAP (mmHg) | 9 | 46 (42–48) | 15 | 50 (41–57) | 0.28 |
| Diastolic PAP (mmHg) | 9 | 21 (17–27) | 15 | 22 (19–25) | 0.61 |
| Mean PAP (mmHg) | 9 | 33 (27–35) | 15 | 30 (27–34) | 0.47 |
| Mean RAP (mmHg) | 9 | 10 (5–10) | 15 | 9 (6–10) | 0.61 |
| PAWP (mmHg) | 9 | 14 (10–17) | 15 | 15 (11–16) | 0.99 |
| Cardiac output (L/min) | 9 | 5.0 (3.4–5.8) | 15 | 4.6 (3.6–5.5) | 1.00 |
| PVR (WU) | 9 | 4.5 (2.8–5.9) | 15 | 3.9 (3.1–5.5) | 0.41 |
| Quality of life measures | |||||
| SOBQ Score | 9 | 39 (35–51) | 15 | 40 (29–57) | 0.99 |
| SGRQ Summary Score | 9 | 59 (36–65) | 15 | 54 (39–60) | 0.73 |
| Symptoms Domain Score | 9 | 69 (30–78) | 15 | 50 (37–65) | 0.92 |
| Activity Domain Score | 9 | 73 (66–87) | 15 | 79 (60–93) | 0.86 |
| Impact Domain Score | 9 | 47 (19–50) | 15 | 30 (16–50) | 0.82 |
| Biochemical data | |||||
| BNP (ng/mL) | 9 | 33 (23–77) | 15 | 73 (39–100) | 0.41 |
| Creatinine (mg/dL) | 9 | 0.9 (0.9–1.1) | 15 | 1.1 (0.8–1.3) | 0.37 |
| Alanine transaminase (U/L) | 9 | 17 (15–33) | 13 | 18 (15–23) | 0.88 |
| Aspartate aminotransferase (U/L) | 9 | 19 (14–26) | 14 | 23 (18–24) | 0.65 |
| International normalized ratio | 9 | 1.0 (1.0–1.1) | 13 | 1.1 (1.0–1.1) | 0.39 |
| Echocardiographic measurements | |||||
| LVEF (%) | 9 | 60 (55–65) | 15 | 60 (55–61) | 0.49 |
| ePASP (mmHg) | 7 | 42 (24–78) | 13 | 39 (34–51) | 0.88 |
| TAPSE (cm) | 7 | 2.2 (1.8–2.5) | 14 | 2.0 (1.6–2.2) | 0.23 |
| LA diameter (cm) | 8 | 3.4 (3.2–3.8) | 15 | 4.2 (3.3–4.7) | 0.14 |
| IVs (mm) | 9 | 9.2 (9.0–10) | 15 | 9.7 (8.1–11) | 0.67 |
| LVEDD (cm) | 8 | 4.7 (4.1–4.9) | 15 | 4.9 (4.0–5.2) | 0.49 |
Note: N is the total number of patients available for analysis. Data are presented as N (%) for categorical variables, mean ± SD for continuous variables that are distributed normally, or median (IQR) for continuous variables that are non‐normally distributed.
Abbreviations: 6WMD, 6 min walk distance; BMI, body mass index; DBp, diastolic blood pressure; DLCO, diffusing capacity for carbon monoxide; ePASP, estimated pulmonary artery pressure derived from the tricuspid regurgitant jet velocity; ERV, expiratory reserve volume; FEV, forced expiratory volume; FRC, functional residual capacity; FVC, forced vital capacity; IVs, interventricular septum; LA, left atrium; LVEDD, LV end‐diastolic dimension; LVEF, left ventricular ejection fraction; PAP, pulmonary artery pressure; PAWP, pulmonary artery wedge pressure; PVR, pulmonary vascular resistance; RAP, right atrial pressure; RV, residual volume; SaO2, oxyhemoglobin saturation; SBp, systolic blood pressure; SGRQ, shortness of breath questionnaire; SGRQ, St. George's Respiratory Questionnaire; TAPSE, tricuspid annular plane systolic excursion; TLC, total lung capacity.