Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure

Martin M. Borggrefe, Thomas Lawo, Christian Butter, Herwig Schmidinger, Maurizio Lunati, Burkert Pieske, Anand Ramdat Misier, Antonio Curnis, Dirk Böcker, Andrew Remppis, Joseph Kautzner, Markus Stühlinger, Christophe Leclerq, Miloš Táborský, Maria Frigerio, Michael K. Parides, Daniel Burkhoff, Gerhard Hindricks

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1019-1028
Number of pages10
JournalEuropean Heart Journal
Volume29
Issue number8
DOIs
StatePublished - Apr 1 2008
Externally publishedYes

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Double-Blind Method
Heart Failure
Placebos
Therapeutics
Placebo Effect
Exercise Tolerance
Left Ventricular Dysfunction
Oxygen Consumption
Cross-Over Studies
Quality of Life
Surveys and Questionnaires

Keywords

  • Cardiopulmonary stress test
  • Event-free survival
  • Heart failure
  • Minnesota Living with Heart Failure Questionnaire

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. / Borggrefe, Martin M.; Lawo, Thomas; Butter, Christian; Schmidinger, Herwig; Lunati, Maurizio; Pieske, Burkert; Misier, Anand Ramdat; Curnis, Antonio; Böcker, Dirk; Remppis, Andrew; Kautzner, Joseph; Stühlinger, Markus; Leclerq, Christophe; Táborský, Miloš; Frigerio, Maria; Parides, Michael K.; Burkhoff, Daniel; Hindricks, Gerhard.

In: European Heart Journal, Vol. 29, No. 8, 01.04.2008, p. 1019-1028.

Research output: Contribution to journalArticle

Borggrefe, MM, Lawo, T, Butter, C, Schmidinger, H, Lunati, M, Pieske, B, Misier, AR, Curnis, A, Böcker, D, Remppis, A, Kautzner, J, Stühlinger, M, Leclerq, C, Táborský, M, Frigerio, M, Parides, MK, Burkhoff, D & Hindricks, G 2008, 'Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure', European Heart Journal, vol. 29, no. 8, pp. 1019-1028. https://doi.org/10.1093/eurheartj/ehn020
Borggrefe, Martin M. ; Lawo, Thomas ; Butter, Christian ; Schmidinger, Herwig ; Lunati, Maurizio ; Pieske, Burkert ; Misier, Anand Ramdat ; Curnis, Antonio ; Böcker, Dirk ; Remppis, Andrew ; Kautzner, Joseph ; Stühlinger, Markus ; Leclerq, Christophe ; Táborský, Miloš ; Frigerio, Maria ; Parides, Michael K. ; Burkhoff, Daniel ; Hindricks, Gerhard. / Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. In: European Heart Journal. 2008 ; Vol. 29, No. 8. pp. 1019-1028.
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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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T1 - Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure

AU - Borggrefe, Martin M.

AU - Lawo, Thomas

AU - Butter, Christian

AU - Schmidinger, Herwig

AU - Lunati, Maurizio

AU - Pieske, Burkert

AU - Misier, Anand Ramdat

AU - Curnis, Antonio

AU - Böcker, Dirk

AU - Remppis, Andrew

AU - Kautzner, Joseph

AU - Stühlinger, Markus

AU - Leclerq, Christophe

AU - Táborský, Miloš

AU - Frigerio, Maria

AU - Parides, Michael K.

AU - Burkhoff, Daniel

AU - Hindricks, Gerhard

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N2 - 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.

AB - 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.

KW - Cardiopulmonary stress test

KW - Event-free survival

KW - Heart failure

KW - Minnesota Living with Heart Failure Questionnaire

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