© 2002 European Society of Cardiology
Dissociation between hemodynamic changes and symptom improvement in patients with advanced congestive heart failure
a Duke Clinical Research Institute P.O. Box 17969, Durham, NC 27715, USA
b Glaxo Wellcome, Inc. P.O. Box 13398, Research Triangle Park, NC 27709, USA
c Department of Cardiology Northwestern University Medical Center, 250 East Superior Street #524, Chicago, IL 60611, USA
d Department of Medicine University of North Carolina at Chapel Hill, 333 Burnett Womack, Chapel Hill, NC 27599, USA
e Department of Cardiology and Thoracic Surgery, Ostra University Sahlgrenska Hospital, SE-416 85 Göteborg, Sweden
* Corresponding author. Tel.: +1-919-668-8776; fax: +1-919-668-7057. E-mail address: shah0013{at}mc.duke.edu
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Abstract |
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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.
Key Words: Hemodynamic measures • Surrogate end points • Advanced heart failure
Received January 30, 2001; Revised June 18, 2001; Accepted August 14, 2001
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