Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure.
OBJECTIVE
We performed a randomized, double blind, crossover study of cardiac contractility modulation (CCM) signals in heart failure patients.


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).


CONCLUSIONS
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.
Borggrefe
Martin M
MM
I. Medizinische Klinik, Klinikum Mannheim GmbH, Universitätsklinikum, Medizinische Fakultät Mannheim der Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. martin.borggrefe@med.ma.uni-heidelberg.de
Lawo
Thomas
T
Butter
Christian
C
Schmidinger
Herwig
H
Lunati
Maurizio
M
Pieske
Burkert
B
Misier
Anand Ramdat
AR
Curnis
Antonio
A
Böcker
Dirk
D
Remppis
Andrew
A
Kautzner
Joseph
J
Stühlinger
Markus
M
Leclerq
Christophe
C
Táborsky
Milos
M
Frigerio
Maria
M
Parides
Michael
M
Burkhoff
Daniel
D
Hindricks
Gerhard
G
D000465:Algorithms; D002304:Cardiac Pacing, Artificial / Q000379:methods; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000379:methods*; D004812:Epidemiologic Methods; D005080:Exercise Test / Q000379:methods; D017079:Exercise Tolerance / Q000502:physiology; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009200:Myocardial Contraction / Q000502:physiology*; D010101:Oxygen Consumption / Q000502:physiology; D013318:Stroke Volume / Q000502:physiology