The rationale for an acute heart failure syndromes clinical trials network.
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.
Collins
Sean P
SP
University of Cincinnati, Cincinnati, OH 45267-0769, USA.
Levy
Phillip D
PD
Lindsell
Christopher J
CJ
Pang
Peter S
PS
Storrow
Alan B
AB
Miller
Chadwick D
CD
Naftilan
Allen J
AJ
Thohan
Vinay
V
Abraham
William T
WT
Hiestand
Brian
B
Filippatos
Gerasimos
G
Diercks
Deborah B
DB
Hollander
Judd
J
Nowak
Richard
R
Peacock
W Frank
WF
Gheorghiade
Mihai
M
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