PMID- 17018340
OWN - NLM
STAT- MEDLINE
DCOM- 20061107
LR  - 20161222
IS  - 1547-5271 (Print)
IS  - 1547-5271 (Linking)
VI  - 3
IP  - 10
DP  - 2006 Oct
TI  - Nonexcitatory, cardiac contractility modulation electrical impulses: feasibility 
      study for advanced heart failure in patients with normal QRS duration.
PG  - 1140-7
AB  - BACKGROUND: Cardiac contractility modulation signals are associated with acutely 
      improved hemodynamics, but chronic clinical impact is not defined. OBJECTIVES: 
      The purpose of this randomized, double-blind, pilot study was to determine the 
      feasibility of safely and effectively delivering cardiac contractility modulation 
      signals in patients with heart failure. METHODS: Forty-nine subjects with 
      ejection fraction <35%, normal QRS duration (105 +/- 15 ms), and New York Heart 
      Association (NYHA) class III or IV heart failure despite medical therapy received 
      a cardiac contractility modulation pulse generator. Patients were randomized to 
      have their devices programmed to deliver cardiac contractility modulation signals 
      (n = 25, treatment group) or to remain off (n = 24, control group) for 6 months. 
      Evaluations included NYHA class, 6-minute walk, cardiopulmonary stress test, 
      Minnesota Living with Heart Failure Questionnaire, and Holter monitoring. 
      RESULTS: Although most baseline features were balanced between groups, ejection 
      fraction (31.4% +/- 7.4% vs 24.9% +/- 6.5%, P = .003), end-diastolic dimension 
      (52.1 +/- 21.4 mm vs 62.5 +/- 6.2 mm, P = .01), peak VO(2) (16.0 +/- 2.9 mL 
      O(2)/kg/min vs 14.3 +/- 2.8 mL O(2)/kg/min, P = .02), and anaerobic threshold 
      (12.3 +/- 2.5 mL O(2)/kg/min vs 10.6 +/- 2.4 mL O(2)/kg/min, P = .01) were worse 
      in the treatment group than in the control group. Nevertheless, one death 
      occurred in the control group, and more patients in the treatment group were free 
      of hospitalization for any cause at 6 months (84% vs 62%). No change in ectopy 
      was observed. Compared with baseline, 6-minute walk (13.4 m), peak VO(2) (0.2 mL 
      O(2)/kg/min), and anaerobic threshold (0.8 mL O(2)/kg/min) increased more in the 
      treatment group than in control. None of these differences were statistically 
      significant (small sample size). NYHA and Minnesota Living with Heart Failure 
      Questionnaire changed similarly in the two groups. CONCLUSION: Despite a sicker 
      population in the treatment group, no specific safety concerns emerged with 
      chronic cardiac contractility modulation signal administration. Further study is 
      required to definitively define the safety and efficacy of cardiac contractility 
      modulation signals.
FAU - Neelagaru, Suresh B
AU  - Neelagaru SB
AD  - Lone Star Arrhythmia and Heart Failure Center, Amarillo, Texas, USA.
FAU - Sanchez, Javier E
AU  - Sanchez JE
FAU - Lau, Stanley K
AU  - Lau SK
FAU - Greenberg, Steven M
AU  - Greenberg SM
FAU - Raval, Nirav Y
AU  - Raval NY
FAU - Worley, Seth
AU  - Worley S
FAU - Kalman, Jill
AU  - Kalman J
FAU - Merliss, Andrew D
AU  - Merliss AD
FAU - Krueger, Steven
AU  - Krueger S
FAU - Wood, Mark
AU  - Wood M
FAU - Wish, Marc
AU  - Wish M
FAU - Burkhoff, Daniel
AU  - Burkhoff D
FAU - Nademanee, Koonlawee
AU  - Nademanee K
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060708
PL  - United States
TA  - Heart Rhythm
JT  - Heart rhythm
JID - 101200317
SB  - IM
CIN - Heart Rhythm. 2006 Oct;3(10):1148-9. PMID: 17018341
MH  - Aged
MH  - Defibrillators, Implantable
MH  - Double-Blind Method
MH  - Electric Countershock/*methods
MH  - Electrocardiography, Ambulatory
MH  - Exercise Test
MH  - Exercise Tolerance/physiology
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/physiopathology/*therapy
MH  - Heart Rate/physiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Contraction/*physiology
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Stroke Volume/physiology
MH  - Treatment Outcome
EDAT- 2006/10/05 09:00
MHDA- 2006/11/09 09:00
CRDT- 2006/10/05 09:00
PHST- 2006/04/27 00:00 [received]
PHST- 2006/06/26 00:00 [accepted]
PHST- 2006/10/05 09:00 [pubmed]
PHST- 2006/11/09 09:00 [medline]
PHST- 2006/10/05 09:00 [entrez]
AID - S1547-5271(06)01727-9 [pii]
AID - 10.1016/j.hrthm.2006.06.031 [doi]
PST - ppublish
SO  - Heart Rhythm. 2006 Oct;3(10):1140-7. doi: 10.1016/j.hrthm.2006.06.031. Epub 2006 
      Jul 8.