Dissociation between hemodynamic changes and symptom improvement in patients with advanced congestive heart failure.

Journal Article (Clinical Trial;Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Shah, MR; Hasselblad, V; Stinnett, SS; Kramer, JM; Grossman, S; Gheorghiade, M; Adams, KF; Swedberg, K; Califf, RM; O'Connor, CM

Published Date

  • June 2002

Published In

Volume / Issue

  • 4 / 3

Start / End Page

  • 297 - 304

PubMed ID

  • 12034155

International Standard Serial Number (ISSN)

  • 1388-9842

Digital Object Identifier (DOI)

  • 10.1016/s1388-9842(01)00202-1


  • eng

Conference Location

  • England