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Table 4 Outcome at 19 months after randomization

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

Placebo

Adjusted Difference 1)

Systolic blood pressure [mmHg]

104 ± 13

n = 19

108 ± 14

n = 14

−2.5 [−10.9 to 5.9]

n = 38

Echocardiography

 Left ventricle fractional shortening [%]

34 ± 3.9

n = 19

33 ± 5.7

n = 15

0.6 [−2.0 to 3.2]

n = 38

 Left ventricle diastolic diameter [cm]

4 ± 0.5

n = 19

4 ± 0.4

n = 15

0.1 [−0.2 to 0.4]

n = 38

 Interventricular septum systolic thickness [cm]

1 ± 0.2

n = 12

1 ± 0.5

n = 8

−0.1 [−1.5 to 1.3]

n = 18

Electrocardiogram (ECG)

 Ventricular heart rate [beats/min]

84 ± 16

n = 18

96 ± 12

n = 15

−4.8 [−12.5 to 2.9]

n = 38

 P-wave [ms]

84 ± 14

n = 18

73 ± 14

n = 15

10.3 [2.1 to 18.6]*

n = 38

 PQ-interval [ms]

129 ± 20

n = 18

115 ± 12

n = 15

10.9 [2.1 to 19.7]*

n = 38

 QRS-time [ms]

102 ± 67

n = 18

86 ± 9

n = 15

5.5 [−2.4 to 13.3]

n = 38

 QTc-time [ms]

405 ± 28

n = 18

415 ± 33

n = 15

−9.2 [−26.4 to 8.0]

n = 38

Holter-Electrocardiogram (Holter-ECG)

 Ventricular heart rate [beats/min]:

 Minimum

68 ± 12

n = 15

75 ± 12

n = 14

−2.6 [−10.5 to 5.3]

n = 32

 Maximum

123 ± 14

n = 15

136 ± 15

n = 14

−16.7[−25.6 to −7.9]*

n = 32

 Mean

91 ± 13

n = 15

101 ± 14

n = 14

−5.2 [−12.8 to 2.3]

n = 32

Heart rate variability (Holter ECG)

 mean NN [ms]

681 ± 86

n = 8

650 ± 82

n = 6

−54.1 [− 160.2 to 52.0]

n = 17

 SDNN [ms]

85 ± 31

n = 9

90 ± 46

n = 7

−17.8 [−52.4 to 16.9]

n = 18

 SDANN [ms]

59 ± 29

n = 9

66 ± 36

n = 7

−19.0 [−47.4 to 9.4]

n = 18

 ASDNN [ms]

52 ± 18

n = 9

55 ± 33

n = 7

−13.0 [−37.5 to 11.6]

n = 18

 rMSSD [ms]

37 ± 15

n = 9

41 ± 32

n = 7

−12.9 [−40.2 to 14.3]

n = 19

 pNN50 [%]

12 ± 9

n = 9

13 ± 14

n = 7

−6.8 [−20.3 to 6.7]

n = 18

Quality of life (KINDL total score) 2)

74.7 ± 12.3

n = 15

76.4 ± 6.4

n = 14

1.5 [−4.3 to 7.4]

n = 36

Biomarker and neurohumoral markers 3)

 NT-proBNP [pg/ml]

90 ± 69

n = 16

52 ± 42

n = 13

12 [− 13 to 38]

n = 28

 Noradrenalin [pg/ml]

355 ± 139

n = 12

188 ± 58

n = 9

124 [21 to 228]*

n = 17

 Renin [pg/ml]

297 ± 357

n = 16

38 ± 43

n = 12

332 [119 to 545]*

n = 27

 Aldosteron [ng/ml]

0.077 ± 0.097

n = 13

0.056 ± 0.036

n = 11

0.032 [−0.027 to 0.090]

n = 24

 Angiotensin II [pmol/ml]

19.4 ± 32.4

n = 16

15.6 ± 13.8

n = 12

−6.1 [−31.3 to 19.1]

n = 27

  1. Data are mean ± SD, n = number of measurements
  2. * difference is statistically significant
  3. 1) Differences adjusted for baseline measurements after run-in; information from subjects with missing values at month 19 included in mixed model for repeated measures
  4. 2) Differences adjusted for KINDL-questionnaire at screening; information from subjects with missing values at month 19 included in mixed model for repeated measures
  5. 3) Measurements were taken at a mean of 19 months (12.1 to 26.2 months). Differences adjusted for measurements at screening
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Orphanet Journal of Rare Diseases

ISSN: 1750-1172