OBJECTIVES: This study hypothesized that peak expiratory flow rate (PEFR) would increase with acute heart failure (AHF) treatment over the first 24 h, related to a Dyspnea Index (DI) change and treatment effect. BACKGROUND:Dyspnea is a key symptom and clinical trial endpoint in AHF, yet objective assessment is lacking. METHODS: In a clinical trial substudy, 421 patients (37 sites) underwentPEFR testing at baseline, 1, 6, and 24 h after randomization to nesiritide or placebo. DI (by Likert scale) was collected at hours 6 and 24. RESULTS: Patients were median age 70 years, and 34% were female; no significant differences between nesiritide or placebo patients existed. Median baseline PEFR was 225 l/min (interquartile range [IQR]: 160 to 300 l/min) and increased to 230 l/min (2.2% increase; IQR: 170 to 315 l/min) by hour 1, 250 l/min (11.1% increase; IQR: 180 to 340 l/min) by hour 6, and 273 l/min (21.3% increase; IQR: 200 to 360 l/min) by 24 h (all p < 0.001). The 24-h PEFR change related to moderate or marked dyspnea improvement by DI (adjusted odds ratio: 1.04 for each 10 l/min improvement [95% confidence interval (CI): 1.07 to 1.10]; p < 0.01). A model incorporating time and treatment over 24 h showed greater PEFR improvement after nesiritide compared with placebo (p = 0.048). CONCLUSIONS:PEFR increases over the first 24 h in AHF and could serve as an AHF endpoint. Nesiritide had a greater effect than placebo on PEFR, and this predicted patients with moderate/marked improvement in dyspnea, thereby providing an objective metric for assessing AHF. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).
RCT Entities:
OBJECTIVES: This study hypothesized that peak expiratory flow rate (PEFR) would increase with acute heart failure (AHF) treatment over the first 24 h, related to a Dyspnea Index (DI) change and treatment effect. BACKGROUND:Dyspnea is a key symptom and clinical trial endpoint in AHF, yet objective assessment is lacking. METHODS: In a clinical trial substudy, 421 patients (37 sites) underwent PEFR testing at baseline, 1, 6, and 24 h after randomization to nesiritide or placebo. DI (by Likert scale) was collected at hours 6 and 24. RESULTS:Patients were median age 70 years, and 34% were female; no significant differences between nesiritide or placebo patients existed. Median baseline PEFR was 225 l/min (interquartile range [IQR]: 160 to 300 l/min) and increased to 230 l/min (2.2% increase; IQR: 170 to 315 l/min) by hour 1, 250 l/min (11.1% increase; IQR: 180 to 340 l/min) by hour 6, and 273 l/min (21.3% increase; IQR: 200 to 360 l/min) by 24 h (all p < 0.001). The 24-h PEFR change related to moderate or marked dyspnea improvement by DI (adjusted odds ratio: 1.04 for each 10 l/min improvement [95% confidence interval (CI): 1.07 to 1.10]; p < 0.01). A model incorporating time and treatment over 24 h showed greater PEFR improvement after nesiritide compared with placebo (p = 0.048). CONCLUSIONS: PEFR increases over the first 24 h in AHF and could serve as an AHF endpoint. Nesiritide had a greater effect than placebo on PEFR, and this predicted patients with moderate/marked improvement in dyspnea, thereby providing an objective metric for assessing AHF. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).
Authors: Sean Collins; Alan B Storrow; Nancy M Albert; Javed Butler; Justin Ezekowitz; G Michael Felker; Gregory J Fermann; Gregg C Fonarow; Michael M Givertz; Brian Hiestand; Judd E Hollander; David E Lanfear; Phillip D Levy; Peter S Pang; W Frank Peacock; Douglas B Sawyer; John R Teerlink; Daniel J Lenihan Journal: J Card Fail Date: 2014-07-18 Impact factor: 5.712
Authors: Robert J Mentz; Xiaojuan Mi; Puza P Sharma; Laura G Qualls; Adam D DeVore; Katherine Waltman Johnson; Gregg C Fonarow; Lesley H Curtis; Adrian F Hernandez Journal: Am J Cardiol Date: 2014-10-15 Impact factor: 2.778
Authors: Sean P Collins; Alan B Storrow; Phillip D Levy; Nancy Albert; Javed Butler; Justin A Ezekowitz; G Michael Felker; Gregory J Fermann; Gregg C Fonarow; Michael M Givertz; Brian Hiestand; Judd E Hollander; David E Lanfear; Peter S Pang; W Frank Peacock; Douglas B Sawyer; John R Teerlink; Daniel J Lenihan Journal: Acad Emerg Med Date: 2014-11-25 Impact factor: 3.451
Authors: Robert J Mentz; Adrian F Hernandez; Amanda Stebbins; Justin A Ezekowitz; G Michael Felker; Gretchen M Heizer; Dan Atar; John R Teerlink; Robert M Califf; Barry M Massie; Vic Hasselblad; Randall C Starling; Christopher M O'Connor; Piotr Ponikowski Journal: Eur J Heart Fail Date: 2012-11-15 Impact factor: 15.534
Authors: Meaghan Lunney; Marinella Ruospo; Patrizia Natale; Robert R Quinn; Paul E Ronksley; Ioannis Konstantinidis; Suetonia C Palmer; Marcello Tonelli; Giovanni Fm Strippoli; Pietro Ravani Journal: Cochrane Database Syst Rev Date: 2020-02-27
Authors: Justin A Ezekowitz; Mohua Podder; Adrian F Hernandez; Paul W Armstrong; Randall C Starling; Christopher M O'Connor; Robert M Califf Journal: BMJ Open Date: 2016-03-17 Impact factor: 2.692
Authors: Yue Yu; Ren-Qi Yao; Yu-Feng Zhang; Su-Yu Wang; Wang Xi; Jun-Nan Wang; Xiao-Yi Huang; Yong-Ming Yao; Zhi-Nong Wang Journal: Mil Med Res Date: 2021-07-09
Authors: Seraj Abualnaja; Mohua Podder; Adrian F Hernandez; John J V McMurray; Randall C Starling; Christopher M O'Connor; Robert M Califf; Paul W Armstrong; Justin A Ezekowitz Journal: J Am Heart Assoc Date: 2015-08-24 Impact factor: 5.501