title: Acute heart failure: perspectives from a randomized trial and a simultaneous registry.
abstract: BACKGROUND
  Randomized controlled trials (RCT) are limited by their generalizability to the broader nontrial population. To provide a context for Acute Study of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial, we designed a complementary registry to characterize clinical characteristics, practice patterns, and in-hospital outcomes of acute heart failure patients.
  
  
  RESULTS
  Eligible patients for the registry included those with a principal diagnosis of acute heart failure (ICD-9-CM 402 and 428; ICD-10 I50.x, I11.0, I13.0, I13.2) from 8 sites participating in ASCEND-HF (n=697 patients, 2007-2010). Baseline characteristics, treatments, and hospital outcomes from the registy were compared with ASCEND-HF RCT patients from 31 Canadian sites (n=465, 2007-2010). Patients in the registry were older, more likely to be female, and have chronic respiratory disease, less likely to have diabetes mellitus: they had a similar incidence of ischemic HF, atrial fibrillation, and similar B-type natriuretic peptide levels. Registry patients had higher systolic blood pressure (registry: median 132 mm Hg [interquartile range 115-151 mm Hg]; RCT: median 120 mm Hg [interquartile range 110-135 mm Hg]) and ejection fraction (registry: median 40% [interquartile range 27-58%]; RCT: median 29% [interquartile range 20-40 mm Hg]) than RCT patients. Registry patients presented more often via ambulance and had a similar total length of stay as RCT patients. In-hospital mortality was significantly higher in the registry compared with the RCT patients (9.3% versus 1.3%,P<0.001), and this remained after multivariable adjustment (odds ratio 6.6, 95% CI 2.6-16.8, P<0.001).
  
  
  CONCLUSIONS
  Patients enrolled in a large RCT of acute heart failure differed significantly based on clinical characteristics, treatments, and inpatient outcomes from contemporaneous patients participating in a registry. These results highlight the need for context of RCTs to evaluate generalizability of results and especially the need to improve clinical outcomes in acute heart failure.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.
authors.affiliation: Mazankowski Alberta Heart Institute and the University of Alberta, Edmonton, AB, Canada. jae2@ualberta.ca
authors.forename: Justin A
authors.initials: JA
authors.lastname: Ezekowitz
authors.forename: Jia
authors.initials: J
authors.lastname: Hu
authors.forename: Diego
authors.initials: D
authors.lastname: Delgado
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
authors.forename: Padma
authors.initials: P
authors.lastname: Kaul
authors.forename: Rolland
authors.initials: R
authors.lastname: Leader
authors.forename: Guy
authors.initials: G
authors.lastname: Proulx
authors.forename: Sean
authors.initials: S
authors.lastname: Virani
authors.forename: Michel
authors.initials: M
authors.lastname: White
authors.forename: Shelley
authors.initials: S
authors.lastname: Zieroth
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Connor
authors.forename: Cynthia M
authors.initials: CM
authors.lastname: Westerhout
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D015331:Cohort Studies; D015897:Comorbidity; D019468:Disease Management; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology* / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D045283:Natriuretic Agents / Q000627:therapeutic use; D020097:Natriuretic Peptide, Brain / Q000627:therapeutic use*; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012189:Retrospective Studies
chemical_list: D045283:Natriuretic Agents; D020097:Natriuretic Peptide, Brain