PMID- 18226768
OWN - NLM
STAT- MEDLINE
DCOM- 20080214
LR  - 20220316
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 14
IP  - 1
DP  - 2008 Feb
TI  - Impact of cardiac resynchronization therapy on exercise performance, functional 
      capacity, and quality of life in systolic heart failure with QRS prolongation: 
      COMPANION trial sub-study.
PG  - 9-18
LID - 10.1016/j.cardfail.2007.08.003 [doi]
AB  - BACKGROUND: A total of 405 participants in the Comparison of Medical Therapy, 
      Pacing, and Defibrillation in Heart Failure trial were prospectively enrolled in 
      an exercise sub-study designed to study the influence of cardiac 
      resynchronization therapy (CRT) on measures of exercise capacity, functional 
      capacity, and quality of life (QOL). METHODS AND RESULTS: Substudy eligibility 
      included New York Heart Association (NYHA) functional Class III or IV heart 
      failure, left ventricular ejection fraction < or =0.35, QRS interval of > or =120 
      ms, normal sinus rhythm, a heart failure hospitalization (or equivalent) within 1 
      year, a peak VO2 < or =22 mL x kg x min, the ability to walk 150 to 425 meters in 
      6 minutes, forced expiratory volume in 1 second/forced vital capacity > or =50%, 
      and no clinical indication for a pacemaker or implantable 
      cardioverter-defibrillator. Patients were randomized in a 1:4 ratio to optimal 
      medical therapy (OPT) or to OPT plus CRT. Cardiopulmonary exercise testing (peak 
      VO2 and 6-minute walk distance [6MWD]) and assessment of NYHA functional class 
      and QOL were assessed at baseline and at 3 and 6 months of assigned therapy. 
      There was no significant improvement in peak VO2 at 6 months in the CRT group 
      compared with the OPT group (+0.63 mL x kg x min) by unadjusted analysis (P = 
      .05) or by analyses adjusted for missing data. Thus the primary end point of the 
      study was not met. There was significantly greater improvement in the 6MWD in the 
      CRT group compared with the OPT group at both 3 and 6 months by both statistical 
      methods (P < or = .045). Likewise, a greater proportion of CRT patients improved 
      by 1 or more NYHA functional classes (P < .01) at 3 months and had better QOL 
      scores (P < .01) at 3 and 6 months compared with the OPT patients. Baseline peak 
      VO2 predicted clinical events (time to death, time to death or first 
      hospitalization, or time to death and first heart failure hospitalization: P < 
      .05) in CRT participants. CONCLUSION: CRT patients with moderate to advanced 
      symptoms of systolic heart failure and prolonged QRS intervals benefit from the 
      addition of CRT to OPT in terms of exercise capacity, functional status, and QOL. 
      CRT should be considered standard therapy in this select group of heart failure 
      patients.
FAU - De Marco, Teresa
AU  - De Marco T
AD  - University of California, San Francisco Medical Center, San Francisco, CA, USA.
FAU - Wolfel, Eugene
AU  - Wolfel E
FAU - Feldman, Arthur M
AU  - Feldman AM
FAU - Lowes, Brian
AU  - Lowes B
FAU - Higginbotham, Michael B
AU  - Higginbotham MB
FAU - Ghali, Jalal K
AU  - Ghali JK
FAU - Wagoner, Lynne
AU  - Wagoner L
FAU - Kirlin, Philip C
AU  - Kirlin PC
FAU - Kennett, Jerry D
AU  - Kennett JD
FAU - Goel, Satish
AU  - Goel S
FAU - Saxon, Leslie A
AU  - Saxon LA
FAU - Boehmer, John P
AU  - Boehmer JP
FAU - Mann, David
AU  - Mann D
FAU - Galle, Elizabeth
AU  - Galle E
FAU - Ecklund, Fred
AU  - Ecklund F
FAU - Yong, Patrick
AU  - Yong P
FAU - Bristow, Michael R
AU  - Bristow MR
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
MH  - Aged
MH  - Combined Modality Therapy
MH  - *Defibrillators, Implantable
MH  - *Electrocardiography
MH  - Exercise Tolerance/*physiology
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure, Systolic/diagnosis/mortality/*therapy
MH  - Heart Function Tests
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - *Pacemaker, Artificial
MH  - Probability
MH  - *Quality of Life
MH  - Reference Values
MH  - Severity of Illness Index
MH  - Stroke Volume/physiology
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Ventricular Remodeling/physiology
EDAT- 2008/01/30 09:00
MHDA- 2008/02/15 09:00
CRDT- 2008/01/30 09:00
PHST- 2006/11/14 00:00 [received]
PHST- 2007/07/27 00:00 [revised]
PHST- 2007/08/01 00:00 [accepted]
PHST- 2008/01/30 09:00 [pubmed]
PHST- 2008/02/15 09:00 [medline]
PHST- 2008/01/30 09:00 [entrez]
AID - S1071-9164(07)01024-X [pii]
AID - 10.1016/j.cardfail.2007.08.003 [doi]
PST - ppublish
SO  - J Card Fail. 2008 Feb;14(1):9-18. doi: 10.1016/j.cardfail.2007.08.003.