PMID- 10089855
OWN - NLM
STAT- MEDLINE
DCOM- 19990407
LR  - 20190622
IS  - 0002-9149 (Print)
IS  - 0002-9149 (Linking)
VI  - 83
IP  - 5B
DP  - 1999 Mar 11
TI  - The Pacing Therapies for Congestive Heart Failure (PATH-CHF) study: rationale, 
      design, and endpoints of a prospective randomized multicenter study.
PG  - 130D-135D
AB  - In conjunction with pharmacologic therapy, pacing has been proposed as a 
      potential treatment to decrease symptoms in patients with moderate-to-severe 
      congestive heart failure (CHF). Uncontrolled studies of pacing therapy for CHF 
      dealing with different pacing sites, modes of pacing, and atrioventricular delays 
      have reported mixed outcomes. The Pacing Therapies in Congestive Heart Failure 
      (PATH-CHF) study is a single-blind, randomized, crossover, controlled trial 
      designed to evaluate the effects of pacing on acute hemodynamic function and to 
      assess chronic clinical benefit in patients with moderate-to-severe CHF. The 
      effect of pacing on oxygen consumption at peak exercise and at anaerobic 
      threshold during cardiopulmonary exercise tests, and on 6-minute walk distance, 
      have been selected as primary endpoints of the study. Secondary endpoints of the 
      trial were changes in New York Heart Association (NYHA) functional class, 
      quality-of-life as assessed by the Minnesota Living with Heart Failure 
      questionnaire, and hospitalization frequency. Finally, changes in ejection 
      fraction, cardiac output, and filling pattern were assessed by echocardiography. 
      The trial was planned to include 53 patients from 7 centers in Europe over a 
      period of 3 years. The study was divided into 2 parts: acute testing and chronic 
      follow-up. The acute study, performed during the pacemaker implantation, involved 
      extensive testing using a custom-designed computer (FLEXSTIM) and a unique burst 
      pacing protocol (FLEXSTIM protocol) to determine the best ventricular pacing 
      sites and the most appropriate atrioventricular delays. The chronic phase 
      consisted of a crossover study designed to test in each patient the best 
      univentricular pacing site and biventricular pacing as assessed by the acute 
      hemodynamic study. The study started with the first implant in 1995 and has, to 
      date, included 42 patients. The study is expected to be completed by the end of 
      1998. The results of a first interim analysis showed trends toward improvement in 
      all primary and secondary endpoints during the pacing periods compared with no 
      pacing.
FAU - Auricchio, A
AU  - Auricchio A
AD  - Department of Cardiology, University Hospital, Magdeburg, Germany.
FAU - Stellbrink, C
AU  - Stellbrink C
FAU - Sack, S
AU  - Sack S
FAU - Block, M
AU  - Block M
FAU - Vogt, J
AU  - Vogt J
FAU - Bakker, P
AU  - Bakker P
FAU - Mortensen, P
AU  - Mortensen P
FAU - Klein, H
AU  - Klein H
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Electrocardiography, Ambulatory/instrumentation
MH  - Exercise Test/instrumentation
MH  - Female
MH  - Heart Atria/physiopathology
MH  - Heart Failure/physiopathology/*therapy
MH  - Heart Ventricles/physiopathology
MH  - Hemodynamics/physiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Pacemaker, Artificial
MH  - Prospective Studies
MH  - Signal Processing, Computer-Assisted/instrumentation
MH  - Stroke Volume/physiology
MH  - Treatment Outcome
EDAT- 1999/03/25 00:00
MHDA- 1999/03/25 00:01
CRDT- 1999/03/25 00:00
PHST- 1999/03/25 00:00 [pubmed]
PHST- 1999/03/25 00:01 [medline]
PHST- 1999/03/25 00:00 [entrez]
AID - S0002-9149(98)01014-5 [pii]
AID - 10.1016/s0002-9149(98)01014-5 [doi]
PST - ppublish
SO  - Am J Cardiol. 1999 Mar 11;83(5B):130D-135D. doi: 10.1016/s0002-9149(98)01014-5.