title: The rationale for an acute heart failure syndromes clinical trials network.
abstract: BACKGROUND
  Clinical trials involving novel therapies treating acute heart failure syndromes (AHFS) have shown limited success with regard to both efficacy and safety. As a direct result, outcomes have changed little over time and AHFS remains a disease process associated with largely no change in hospitalization rates (80%), hospital length of stay (median 4.5 days), and in-hospital (4-7%) and 60-day mortality (10%). Despite extensive emergency department (ED) involvement during the initial phase of AHFS management, clinical trials have enrolled patients after the ED phase of management, up to 48 hours after initial therapy, long after many patients have experienced significant beneficial effects of standard therapy. As standard therapy has provided symptomatic improvement in up to 70% of patients in these trials, it is not surprising that investigational agents started after 24 to 48 hours of standard therapy have shown limited clinical efficacy when compared with standard therapy.
  
  
  RESULTS
  The ability to screen, enroll, and randomize in the emergency setting is fundamental. The unique environment, the ethical complexities of enrollment in emergency-based research, and the need for rapid and standardized study-compliant care represent key challenges to active recruitment in AHFS studies. Specifically, the ability to identify and enroll a large cohort of AHFS patients early (<6 hours) in their presentation has been cited as the primary barrier to the appropriate design of clinical trials that includes this early window.
  
  
  CONCLUSIONS
  In response, we have created a network of dedicated academic physicians with experience in clinical trials and acute management of heart failure who together can surmount this barrier and provide a framework for conducting early trials in AHFS.
authors: University of Cincinnati, Cincinnati, OH 45267-0769, USA.
authors: Sean P
authors: SP
authors: Collins
authors: Phillip D
authors: PD
authors: Levy
authors: Christopher J
authors: CJ
authors: Lindsell
authors: Peter S
authors: PS
authors: Pang
authors: Alan B
authors: AB
authors: Storrow
authors: Chadwick D
authors: CD
authors: Miller
authors: Allen J
authors: AJ
authors: Naftilan
authors: Vinay
authors: V
authors: Thohan
authors: William T
authors: WT
authors: Abraham
authors: Brian
authors: B
authors: Hiestand
authors: Gerasimos
authors: G
authors: Filippatos
authors: Deborah B
authors: DB
authors: Diercks
authors: Judd
authors: J
authors: Hollander
authors: Richard
authors: R
authors: Nowak
authors: W Frank
authors: WF
authors: Peacock
authors: Mihai
authors: M
authors: Gheorghiade
mesh_terms: D000208:Acute Disease; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D015331:Cohort Studies; D006333:Heart Failure / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D007255:Information Services / Q000592:standards*; D012042:Registries / Q000592:standards; D013577:Syndrome