Design and rationale of the URGENT Dyspnea study: an international, multicenter, prospective study.
BACKGROUND
Dyspnea is a key target in both clinical management and clinical trials of acute heart failure syndromes and its relief important to patients, clinicians, investigators, and regulatory approval agencies. Despite its importance, the impact of early therapy on dyspnea is not well known. The severity of dyspnea may also be influenced by the conditions under which it is measured (ie, sitting up or lying down). URGENT Dyspnea (Ularitide Global Evaluation in Acute Decompensated Heart Failure) is a prospective multicenter study designed to address these issues.


RESULTS
Consenting adult patients with dyspnea secondary to acute heart failure syndromes are eligible. Patients must be interviewed within one hour of first physician evaluation, typically in an emergency department or acute care setting, with dyspnea assessed by the patient using both a 5-point Likert scale and 10-point visual analog scale in the sitting (60 degrees) and then supine (20 degrees ) position if symptomatically able. Improvement of dyspnea by change in Likert and visual analog scale scores at 6 h is the primary endpoint.


CONCLUSIONS
Timing of dyspnea measurement and the conditions under which it is measured may influence dyspnea severity and this may have significant implications for future acute heart failure syndromes clinical trial design that target dyspnea.
Pang
Peter S
PS
Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. ppang@northwestern.edu
Tavares
Miguel
M
Collins
Sean P
SP
Cleland
John G F
JG
Hollander
Judd
J
Nieminen
Markku
M
Miller
Chadwick
C
Courtney
D Mark
DM
Kirk
J Douglas
JD
Masip
Josep
J
Parkhomenko
Alexander
A
Macarie
Cezar
C
Peacock
W Frank
WF
Spinar
Jindrich
J
Nowak
Richard
R
Raev
Dimitar
D
Storrow
Alan B
AB
Spisak
Vladimir
V
Hamdy
Ahmed
A
Mebazaa
Alexandre
A
Gheorghiade
Mihai
M
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic / Q000379:methods*; D004417:Dyspnea / Q000628:therapy*; D006333:Heart Failure; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors