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Borggrefe, MM; Lawo, T; Butter, C; Schmidinger, H; Lunati, M; Pieske, B; Misier, AR; Curnis, A; Bocker, D; Remppis, A; Kautzner, J; Stuhlinger, M; Leclerq, C; Taborsky, M; Frigerio, M; Parides, M; Burkhoff, D; Hindricks, G.
Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure.
Eur Heart J. 2008; 29(8):1019-1028
Doi: 10.1093/eurheartj/ehn020
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- Co-Autor*innen der Med Uni Graz
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Pieske Burkert Mathias
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- Abstract:
- Aims We performed a randomized, double blind, crossover study of cardiac contractility modulation (CCM) signals in heart failure patients. Methods and results One hundred and sixty-four subjects with ejection fraction (EF)< 35% and NYHA Class II (24%) or III (76%) symptoms received a CCM pulse generator. Patients were randomly assigned to Group 1 (n=80, CCM treatment 3 months, sham treatment second 3 months) or Group 2 (n=84, sham treatment 3 months, CCM treatment second 3 months). The co-primary endpoints were changes in peak oxygen consumption (VO2,peak) and Minnesota Living with Heart Failure Questionnaire (MLWHFQ). Baseline EF (29.3 +/- 6.7% vs. 29.8 +/- 7.8%), VO2,peak (14.1 +/- 3.0 vs. 13.6 +/- 2.7 mL/kg/min), and MLWHFQ (38.9 +/- 27.4 vs. 36.5 +/- 27.1) were similar between the groups. VO2,peak increased similarly in both groups during the first 3 months (0.40 +/- 3.0 vs. 0.37 +/- 3.3 mL/kg/min, placebo effect). During the next 3 months, VO2,peak decreased in the group switched to sham (-0.86 +/- 3.06 mL/kg/min) and increased in patients switched to active treatment (0.16 +/- 2.50 mL/kg/min). MLWHFQ trended better with treatment (-12.06 +/- 15.33 vs. -9.70 +/- 16.71) during the first 3 months, increased during the second 3 months in the group switched to sham (+4.70 +/- 16.57), and decreased further in patients switched to active treatment (-0.70 +/- 15.13). A comparison of values at the end of active treatment periods vs. end of sham treatment periods indicates statistically significantly improved VO2,peak and MLWHFQ (P=0.03 for each parameter). Conclusion In patients with heart failure and left ventricular dysfunction, CCM signals appear safe; exercise tolerance and quality of life (MLWHFQ) were significantly better while patients were receiving active treatment with CCM for a 3-month period.
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Exercise Test - methods
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Exercise Tolerance - physiology
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Heart Failure - physiopathology Heart Failure - therapy
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heart failure
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cardiopulmonary stress test
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Minnesota living with heart failure questionnaire
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event-free survival