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Table 3 Baseline characteristics by randomized treatment (end of run-in therapy)

From: Effect and safety of treatment with ACE-inhibitor Enalapril and β-blocker metoprolol on the onset of left ventricular dysfunction in Duchenne muscular dystrophy - a randomized, double-blind, placebo-controlled trial

 

Enalapril and Metoprolol 1)

Placebo 1)

Age [years]

12 ± 1.2

n = 21

11 ± 1.1

n = 17

Body Mass Index [kg/m2]

23 ± 6

n = 20

21 ± 5

n = 17

Ability to rise from supine position

24%

5/21

24%

4/17

Preserved ability to walk

33%

7/21

41%

5/17

Maximum walking distance [m]

200 (3–6000)2)

n = 7

300 (30–800)2)

n = 5

Systolic blood pressure [mmHg]

103 ± 16

n = 21

101 ± 11

n = 17

Patients with presence of cardiac symptoms

0%

0/21

0%

0/17

Steroid use or history of steroid use

76%

16/21

59%

10/17

NYHA class

 Not applicable

52%

11/21

59%

10/17

 NYHA class I

48%

10/21

35%

6/17

 NYHA class II

0%

0/21

6%

1/17

Quality of life (KINDL total score at screening)

70.8 ± 10.1

n = 21

75.6 ± 10.0

n = 17

Echocardiography

n = 21

 

n = 17

 Left ventricle fractional shortening [%]

35 ± 3

 

36 ± 4

 

Electrocardiogram (ECG)

n = 21

 

n = 17

 Ventricular heart rate [beats/min]

84 ± 14

 

94 ± 16

 

Holter-Electrocardiogram (Holter-ECG)

n = 20

 

n = 15

Ventricular heart rate [beats/min]

 minimum

67 ± 12

 

72 ± 10

 

 maximum

126 ± 17

 

133 ± 11

 

 mean

90 ± 12

 

97 ± 9

 

Heart rate variability (Holter ECG)

n = 11

 

n = 10

 Mean NN [ms]

678 ± 80

 

571 ± 174

 

 SDNN [ms]

98 ± 29

 

96 ± 30

 

 SDANN [ms]

71 ± 24

 

75 ± 25

 

 ASDNN [ms]

60 ± 20

 

54 ± 21

 

 rMSSD [ms]

46 ± 26

 

45 ± 21

 

 pNN50 [%]

17 ± 15

 

13 ± 11

 
  1. 1) Data are mean ± SD or percentage, n = number of measurements
  2. 2) Data are mean, (minimum-maximum), n = number of measurements
  3. Demographic data were collected at screening, baseline data from echocardiography, ECG and Holter-ECG refer to measurements after run-in/before randomization