Table 1 Patient characteristics
Placebo (N = 116) | Tadalafil 0.3 mg/kg (N = 102) | Tadalafil 0.6 mg/kg (N = 113) | |
|---|---|---|---|
Age, years | 9.4 (1.76) | 9.9 (2.26) | 9.5 (1.71) |
BMI, kg/m2 | 19.7 (4.45) | 20.2 (4.26) | 19.6 (4.79) |
Vital signs | |||
Systolic blood pressure, mmHg | 107.2 (10.7) | 108.6 (10.6) | 109.9 (11.3) |
Diastolic blood pressure, mmHg | 66.7 (10.2) | 65.8 (10.7) | 66.0 (10.7) |
Heart rate, beats per minute | 94.8 (11.7) | 96.1 (12.2) | 93.5 (13.7) |
Echocardiography parameters | |||
LVEF, % | 63.5 (6.4) | 63.2 (5.6) | 62.4 (6.8) |
LV shortening fraction, % | 35.0 (6.3) | 35.5 (5.2) | 34.7 (5.5) |
LVIDd, cm | 3.96 (0.39) | 4.00 (0.42) | 4.02 (0.40) |
LVIDs, cm | 2.58 (0.39) | 2.59 (0.36) | 2.63 (0.36) |
Cardiac medications, n (%) | |||
ACE inhibitors | 20 (17.2) | 27 (26.5) | 20 (17.7) |
Ubiquinone | 14 (12.1) | 10 (9.8) | 8 (7.1) |
Angiotensin II antagonists | 5 (4.3) | 3 (2.9) | 3 (2.7) |
Beta-blocking agents | 2 (1.7) | 3 (2.9) | 1 (0.9) |
CMR parameters (Substudy N = 27) | Placebo (N = 9) | Tadalafil 0.3 mg/kg (N = 10) | Tadalafil 0.6 mg/kg (N = 8) |
LVEF, % | 59.8 (5.2) | 59.6 (5.0) | 59.2 (2.2) |
Circumferential strain, % | -23.2 (3.5) | -22.1 (2.3) | -22.8 (9.8) |
LV end diastolic volume, mL | 74.3 (19.2) | 68.7 (12.4) | 77.3 (31.9) |
LV end systolic volume, mL | 29.5 (6.4) | 28.2 (8.1) | 31.9 (14.8) |
LV stroke volume, mL | 44.8 (13.8) | 40.5 (5.0) | 45.4 (17.1) |
Cardiac output, L/min | 4.2 (1.1) | 4.1 (0.7) | 4.6 (1.2) |
LV mass, g | 44.5 (12.9) | 39.0 (7.8) | 46.5 (17.0) |