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

Monica R. Shah*, Vic Hasselblad, Sandra S. Stinnett, Judith M. Kramer, Steven Grossman, Mihai Gheorghiade, Kirkwood F. Adams, Karl Swedberg, Robert M. Califf, Christopher M. O'Connor

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

40 Scopus citations

Abstract

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 ≤25% for ≥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.

Original languageEnglish (US)
Pages (from-to)297-304
Number of pages8
JournalEuropean Journal of Heart Failure
Volume4
Issue number3
DOIs
StatePublished - Jun 2002

Keywords

  • Advanced heart failure
  • Hemodynamic measures
  • Surrogate end points

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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