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European Heart Journal Advance Access originally published online on February 12, 2008
European Heart Journal 2008 29(8):1019-1028; doi:10.1093/eurheartj/ehn020
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org
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Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure

Martin M. Borggrefe1,*, Thomas Lawo2, Christian Butter3, Herwig Schmidinger4, Maurizio Lunati5, Burkert Pieske6, Anand Ramdat Misier7, Antonio Curnis8, Dirk Böcker9, Andrew Remppis10, Joseph Kautzner11, Markus Stühlinger12, Christophe Leclerq13, Milos Táborsky14, Maria Frigerio5, Michael Parides15, Daniel Burkhoff15,16 and Gerhard Hindricks17

1 I. Medizinische Klinik, Klinikum Mannheim GmbH, Universitätsklinikum, Medizinische Fakultät Mannheim der Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
2 University Hospital Bochum—‘Bergmannsheil’, Bochum, Germany
3 Heart Center Brandenburg in Bernau, Berlin, Germany
4 Medical University of Vienna, Vienna, Austria
5 A.O. Niguarda, Milan, Italy
6 University Hospital Göttingen, Göttingen, Germany
7 Isala Clinics, Zwolle, The Netherlands
8 Spedali Civili of Brescia, Brescia, Italy
9 University of Münster, Münster, Germany
10 University of Heidelberg, Heidelberg, Germany
11 Institute for Clinical and Experimental Medicine, Prague, Czech Republic
12 Innsbruck Medical University, Innsbruck, Austria
13 CHU Pontchaillou, Rennes, France
14 Na Homolce Hospital, Prague, Czech Republic
15 Columbia University, New York City, USA
16 IMPULSE Dynamics, Orangeburg, USA
17 Heart Center Leipzig, Leipzig, Germany

Received 2 June 2007; revised 11 December 2007; accepted 10 January 2008; online publish-ahead-of-print 12 February 2008.

* Corresponding author. Tel +49 621 383 2204, Fax: +49 621 383 3821, Email: martin.borggrefe{at}med.ma.uni-heidelberg.de

See page 961 for the editorial comment on this article (doi:10.1093/eurheartj/ehn127)

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.

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


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