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


OBJECTIVE
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.


CONCLUSIONS
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.
Shah
Monica R
MR
Duke Clinical Research Institute, P.O. Box 17969,Durham, NC 27715, USA. shah0013@mc.duke.edu
Hasselblad
Vic
V
Stinnett
Sandra S
SS
Kramer
Judith M
JM
Grossman
Steven
S
Gheorghiade
Mihai
M
Adams
Kirkwood F
KF
Swedberg
Karl
K
Califf
Robert M
RM
O'Connor
Christopher M
CM
D000368:Aged; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000627:therapeutic use; D004417:Dyspnea / Q000503:physiopathology; D011464:Epoprostenol / Q000627:therapeutic use; D005260:Female; D006333:Heart Failure / Q000188:drug therapy / Q000503:physiopathology*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D013318:Stroke Volume
D000959:Antihypertensive Agents; D011464:Epoprostenol