PMID- 12034155
OWN - NLM
STAT- MEDLINE
DCOM- 20021016
LR  - 20190513
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 4
IP  - 3
DP  - 2002 Jun
TI  - Dissociation between hemodynamic changes and symptom improvement in patients with 
      advanced congestive heart failure.
PG  - 297-304
AB  - BACKGROUND: Changes in hemodynamic measures often serve as surrogate end points 
      in efficacy trials for advanced heart failure, although there are few objective 
      data to support this practice. AIMS: We compared changes in hemodynamic variables 
      vs. changes in symptoms of decompensated heart failure in patients enrolled in a 
      randomized trial. METHODS: We studied 201 patients with New York Heart 
      Association (NYHA) class IIIb or IV heart failure and ejection fraction < or = 
      25% for > or = 3 months. Patients underwent continuous monitoring by 
      pulmonary-artery catheter during inpatient drug administration. We assessed the 
      relations of changes in hemodynamic variables (baseline minus final measure) to 
      changes at 2 weeks in congestive heart failure symptoms, NYHA class, Yale 
      Dyspnea-Fatigue Index (YDFI) score, and distance achieved in a 6-min walk. 
      RESULTS: No hemodynamic measure significantly predicted either symptom score or 
      NYHA classification. Mean pulmonary artery pressure and pulmonary capillary wedge 
      pressure did show some relation to change in YDFI score in univariable, but not 
      multivariable, analysis. No hemodynamic measure correlated significantly with 
      changes in distance achieved in the 6-min walk test. CONCLUSION: We noted no 
      significant association between improved hemodynamics and improved symptoms in 
      patients with advanced heart failure. Other measures may need to be evaluated as 
      surrogate end points in future trials.
FAU - Shah, Monica R
AU  - Shah MR
AD  - Duke Clinical Research Institute, P.O. Box 17969,Durham, NC 27715, USA. 
      shah0013@mc.duke.edu
FAU - Hasselblad, Vic
AU  - Hasselblad V
FAU - Stinnett, Sandra S
AU  - Stinnett SS
FAU - Kramer, Judith M
AU  - Kramer JM
FAU - Grossman, Steven
AU  - Grossman S
FAU - Gheorghiade, Mihai
AU  - Gheorghiade M
FAU - Adams, Kirkwood F Jr
AU  - Adams KF Jr
FAU - Swedberg, Karl
AU  - Swedberg K
FAU - Califf, Robert M
AU  - Califf RM
FAU - O'Connor, Christopher M
AU  - O'Connor CM
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Antihypertensive Agents)
RN  - DCR9Z582X0 (Epoprostenol)
SB  - IM
MH  - Aged
MH  - Analysis of Variance
MH  - Antihypertensive Agents/therapeutic use
MH  - Dyspnea/physiopathology
MH  - Epoprostenol/therapeutic use
MH  - Female
MH  - Heart Failure/drug therapy/*physiopathology
MH  - Hemodynamics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Predictive Value of Tests
MH  - Stroke Volume
EDAT- 2002/05/30 10:00
MHDA- 2002/10/17 04:00
CRDT- 2002/05/30 10:00
PHST- 2002/05/30 10:00 [pubmed]
PHST- 2002/10/17 04:00 [medline]
PHST- 2002/05/30 10:00 [entrez]
AID - S1388984201002021 [pii]
AID - 10.1016/s1388-9842(01)00202-1 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2002 Jun;4(3):297-304. doi: 10.1016/s1388-9842(01)00202-1.