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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