Screening1) | End of run-in1) | Change from screening to end of run-in2) | ||||
---|---|---|---|---|---|---|
Dose level after run-in | ||||||
maximum dose | – | – | 76% | 29/38 | – | – |
step 3 dose | – | – | 18% | 7/38 | – | – |
step 2 dose | – | – | 5% | 2/38 | – | – |
Systolic blood pressure [mmHg] | 111 ± 13 | n = 41 | 102 ± 14 | n = 38 | −9 [−13 to −5]* | n = 37 |
Echocardiography | ||||||
Left ventricle fractional shortening [%] | 35 ± 3 | n = 42 | 36 ± 4 | n = 38 | 0 [−1 to 2] | n = 38 |
Electrocardiogram (ECG) | ||||||
Ventricular heart rate [beats/min] | 97 ± 14 | n = 41 | 88 ± 16 | n = 38 | −9 [−13 to −4]* | n = 37 |
Holter-Electrocardiogram (Holter-ECG) | ||||||
Ventricular heart rate [beats/min]: | ||||||
minimum | 73 ± 10 | n = 38 | 69 ± 11 | n = 35 | −2 [−6 to 2] | n = 34 |
maximum | 140 ± 15 | n = 38 | 129 ± 15 | n = 35 | −11 [−16 to −6]* | n = 34 |
mean | 101 ± 13 | n = 38 | 93 ± 11 | n = 35 | −8 [−13 to −3]* | n = 34 |
Heart rate variability (Holter ECG) | ||||||
mean NN [ms] | 574 ± 122 | n = 23 | 627 ± 140 | n = 21 | 52 [24 to 81]* | n = 19 |
SDNN [ms] | 85 ± 23 | n = 22 | 97 ± 29 | n = 21 | 12 [3 to 21]* | n = 19 |
SDANN [ms] | 69 ± 24 | n = 23 | 73 ± 24 | n = 21 | 0 [−12 to 13] | n = 20 |
ASDNN [ms] | 45 ± 18 | n = 22 | 57 ± 21 | n = 21 | 11 [5 to 18]* | n = 19 |
rMSSD [ms] | 35 ± 18 | n = 24 | 46 ± 23 | n = 22 | 9 [−1 to 18] | n = 21 |
pNN50 [%] | 9 ± 8 | n = 24 | 15 ± 13 | n = 21 | 5 [1 to 10]* | n = 20 |