Priyesh A Patel1, Gretchen Heizer2, Christopher M O'Connor2, Phillip J Schulte2, Kenneth Dickstein2, Justin A Ezekowitz2, Paul W Armstrong2, Vic Hasselblad2, Roger M Mills2, John J V McMurray2, Randall C Starling2, W H Wilson Tang2, Robert M Califf2, Adrian F Hernandez2. 1. From the Duke Clinical Research Institute, Durham, NC (P.A.P., G.H., C.M.O., P.J.S., V.H., R.M.C., A.F.H.); Duke University Medical Center, Durham, NC (C.M.O., R.M.C., A.F.H.); Central Hospital Cardiology Division, Stavanger, Norway (K.D.); Division of Cardiology, Department of Medicine, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Canada (J.A.E., P.W.A.); Janssen Research & Development, LLC, Raritan, NJ (R.M.M.); Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M.); Cleveland Clinic Foundation, OH (R.C.S., W.H.W.T.). priyesh.patel@dm.duke.edu. 2. From the Duke Clinical Research Institute, Durham, NC (P.A.P., G.H., C.M.O., P.J.S., V.H., R.M.C., A.F.H.); Duke University Medical Center, Durham, NC (C.M.O., R.M.C., A.F.H.); Central Hospital Cardiology Division, Stavanger, Norway (K.D.); Division of Cardiology, Department of Medicine, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Canada (J.A.E., P.W.A.); Janssen Research & Development, LLC, Raritan, NJ (R.M.M.); Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M.); Cleveland Clinic Foundation, OH (R.C.S., W.H.W.T.).
Abstract
BACKGROUND: Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood. METHODS AND RESULTS: Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF), we assessed factors associated with in-hospital hypotension and subsequent 30-day outcomes. Patients were classified as having symptomatic or asymptomatic hypotension. Multivariable logistic regression was used to determine factors associated with in-hospital hypotension, and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes. We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge. Overall, 1555 of 7141 (21.8%) patients had an episode of hypotension, of which 73.1% were asymptomatic and 26.9% were symptomatic. Factors strongly associated with in-hospital hypotension included randomization to nesiritide (odds ratio, 1.98; 95% confidence interval [CI], 1.76-2.23; P<0.001), chronic metolazone therapy (odds ratio, 1.74; 95% CI, 1.17-2.60; P<0.001), and baseline orthopnea (odds ratio, 1.31; 95% CI, 1.13-1.52; P=0.001) or S3 gallop (odds ratio, 1.21; 95% CI, 1.06-1.40; P=0.006). In-hospital hypotension was associated with increased hazard of 30-day mortality (hazard ratio, 2.03; 95% CI, 1.57-2.61; P<0.001), 30-day heart failure hospitalization or mortality (hazard ratio, 1.58; 95% CI, 1.34-1.86; P<0.001), and 30-day all-cause hospitalization or mortality (hazard ratio, 1.40; 95% CI, 1.22-1.61; P<0.001). Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes (interaction P=0.874 for death, P=0.908 for death/heart failure hospitalization, P=0.238 death/all-cause hospitalization). CONCLUSIONS:Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse 30-day outcomes, and its occurrence highlights the need for modified treatment strategies. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.
RCT Entities:
BACKGROUND: Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood. METHODS AND RESULTS: Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF), we assessed factors associated with in-hospital hypotension and subsequent 30-day outcomes. Patients were classified as having symptomatic or asymptomatic hypotension. Multivariable logistic regression was used to determine factors associated with in-hospital hypotension, and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes. We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge. Overall, 1555 of 7141 (21.8%) patients had an episode of hypotension, of which 73.1% were asymptomatic and 26.9% were symptomatic. Factors strongly associated with in-hospital hypotension included randomization to nesiritide (odds ratio, 1.98; 95% confidence interval [CI], 1.76-2.23; P<0.001), chronic metolazone therapy (odds ratio, 1.74; 95% CI, 1.17-2.60; P<0.001), and baseline orthopnea (odds ratio, 1.31; 95% CI, 1.13-1.52; P=0.001) or S3 gallop (odds ratio, 1.21; 95% CI, 1.06-1.40; P=0.006). In-hospital hypotension was associated with increased hazard of 30-day mortality (hazard ratio, 2.03; 95% CI, 1.57-2.61; P<0.001), 30-day heart failure hospitalization or mortality (hazard ratio, 1.58; 95% CI, 1.34-1.86; P<0.001), and 30-day all-cause hospitalization or mortality (hazard ratio, 1.40; 95% CI, 1.22-1.61; P<0.001). Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes (interaction P=0.874 for death, P=0.908 for death/heart failure hospitalization, P=0.238 death/all-cause hospitalization). CONCLUSIONS:Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse 30-day outcomes, and its occurrence highlights the need for modified treatment strategies. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.
Authors: Mihai Gheorghiade; Muthiah Vaduganathan; Andrew Ambrosy; Michael Böhm; Umberto Campia; John G F Cleland; Francesco Fedele; Gregg C Fonarow; Aldo P Maggioni; Alexandre Mebazaa; Mandeep Mehra; Marco Metra; Savina Nodari; Peter S Pang; Piotr Ponikowski; Hani N Sabbah; Michel Komajda; Javed Butler Journal: Heart Fail Rev Date: 2013-03 Impact factor: 4.214
Authors: G Michael Felker; Jeffrey D Leimberger; Robert M Califf; Michael S Cuffe; Barry M Massie; Kirkwood F Adams; Mihai Gheorghiade; Christopher M O'Connor Journal: J Card Fail Date: 2004-12 Impact factor: 5.712
Authors: Michael S Cuffe; Robert M Califf; Kirkwood F Adams; Raymond Benza; Robert Bourge; Wilson S Colucci; Barry M Massie; Christopher M O'Connor; Ileana Pina; Rebecca Quigg; Marc A Silver; Mihai Gheorghiade Journal: JAMA Date: 2002-03-27 Impact factor: 56.272
Authors: R M Califf; K F Adams; W J McKenna; M Gheorghiade; B F Uretsky; S E McNulty; H Darius; K Schulman; F Zannad; E Handberg-Thurmond; F E Harrell; W Wheeler; J Soler-Soler; K Swedberg Journal: Am Heart J Date: 1997-07 Impact factor: 4.749
Authors: Mihai Gheorghiade; William T Abraham; Nancy M Albert; Barry H Greenberg; Christopher M O'Connor; Lilin She; Wendy Gattis Stough; Clyde W Yancy; James B Young; Gregg C Fonarow Journal: JAMA Date: 2006-11-08 Impact factor: 56.272
Authors: John E A Blair; Faiez Zannad; Marvin A Konstam; Thomas Cook; Brian Traver; John C Burnett; Liliana Grinfeld; Holly Krasa; Aldo P Maggioni; Cesare Orlandi; Karl Swedberg; James E Udelson; Christopher Zimmer; Mihai Gheorghiade Journal: J Am Coll Cardiol Date: 2008-11-11 Impact factor: 24.094
Authors: Adrian F Hernandez; Christopher M O'Connor; Randall C Starling; Craig J Reist; Paul W Armstrong; Kenneth Dickstein; Todd J Lorenz; W Brian Gibler; Vic Hasselblad; Michel Komajda; Barry Massie; John J V McMurray; Markku Nieminen; Jean L Rouleau; Karl Swedberg; Robert M Califf Journal: Am Heart J Date: 2008-12-19 Impact factor: 4.749
Authors: Clyde W Yancy; Henry Krum; Barry M Massie; Marc A Silver; Lynne Warner Stevenson; Mei Cheng; Sun Sook Kim; Rosemary Evans Journal: Circ Heart Fail Date: 2008-05 Impact factor: 8.790
Authors: Poghni A Peri-Okonny; Xiaojuan Mi; Yevgeniy Khariton; Krishna K Patel; Laine Thomas; Gregg C Fonarow; Puza P Sharma; Carol I Duffy; Nancy M Albert; Javed Butler; Adrian F Hernandez; Kevin McCague; Fredonia B Williams; Adam D DeVore; J Herbert Patterson; John A Spertus Journal: JACC Heart Fail Date: 2019-02-06 Impact factor: 12.035
Authors: Amanda K Verma; Jie-Lena Sun; Adrian Hernandez; John R Teerlink; Phillip J Schulte; Justin Ezekowitz; Adriaan Voors; Randall Starling; Paul Armstrong; Christopher M O'Conner; Robert J Mentz Journal: Clin Cardiol Date: 2018-07-17 Impact factor: 2.882
Authors: Gad Cotter; Beth A Davison; Javed Butler; Sean P Collins; Justin A Ezekowitz; G Michael Felker; Gerasimos Filippatos; Phillip D Levy; Marco Metra; Piotr Ponikowski; John R Teerlink; Adriaan A Voors; Stefanie Senger; David Bharucha; Kathleen Goin; David G Soergel; Peter S Pang Journal: Clin Res Cardiol Date: 2017-10-06 Impact factor: 5.460
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: Luigi Mario Castello; Luca Molinari; Alessandra Renghi; Elena Peruzzi; Andrea Capponi; Gian Carlo Avanzi; Mario Pirisi Journal: Medicine (Baltimore) Date: 2017-07 Impact factor: 1.889