Geographic Differences in Patients in a Global Acute Heart Failure Clinical Trial (from the ASCEND-HF Trial).
A growing number of countries and geographical regions are involved in major clinical trials. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure is the largest trial in acutely decompensated heart failure (HF) with patients from 5 geographical regions: North America (NA), Latin America (LA), Western Europe (WE), Central Europe (CE), and Asia-Pacific (AP). Data from the 5 geographical areas were compared including baseline characteristics, medications, 30-day outcomes (mortality and mortality or HF hospitalization), and 180-day mortality. Of the 7,141 study patients, 3,243 (45.4%) were from NA (average of 15.2 patients/site), 1,762 (24.7%) from AP (28.4 patients/site), 967 (13.5%) from CE (20.2 patients/site), 665 (9.3%) from LA (17.1 patients/site), and 504 (7.1%) from WE (14.4 patients/site). There were marked differences in co-morbidities, clinical profile, medication use, length of stay, 30-day event rates, and 180-day mortality by region. Compared with NA, the adjusted risk for death or HF hospitalization at 30 days was significantly lower in CE (odds ratio [OR] 0.46, 95% CI 0.33 to 0.64), WE (OR 0.52 95% CI 0.35 to 0.75), and AP (OR 0.62 95% CI 0.48 to 0.79) and numerically lower in LA (OR 0.77, 95% CI 0.57 to 1.04) with similar results for 180-day mortality. In conclusion, in patients with acutely decompensated HF, major differences in baseline characteristics, treatments, length of the hospital stay, and 30-day HF rehospitalization rates, and 180-day mortality were found in patients enrolled from different geographical areas.
Division of Cardiology, Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy. Electronic address: metramarco@libero.it.
Marco
M
Metra
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Robert J
RJ
Mentz
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Adrian F
AF
Hernandez
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Gretchen M
GM
Heizer
Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.
Paul W
PW
Armstrong
Serviço de Cardiologia, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.
Nadine
N
Clausell
Cardiovascular Division, Pontificia Universidad Catolica deChile, Santiago, Chile.
Ramon
R
Corbalan
Advocate Heart Institute, Naperville, Illinois.
Maria Rosa
MR
Costanzo
Cardiology Division, Stavenger University Hospital, University of Bergen, Bergen, Norway.
Kenneth
K
Dickstein
Heart and Vascular Center, Metrohealth Medical Center, Cleveland, Ohio.
Mark E
ME
Dunlap
Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.
Justin A
JA
Ezekowitz
Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.
Jonathan G
JG
Howlett
Pitie Salpetriere Hospital, University Pierre Marie Curie, Paris, France.
Michel
M
Komajda
Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Australia.
Henry
H
Krum
Division of Cardiology, Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy.
Carlo
C
Lombardi
Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, California.
Gregg C
GC
Fonarow
BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
John J V
JJ
McMurray
Heart and Lung Center, Meilahti Hospital, Helsinki, Finland.
Markku S
MS
Nieminen
Department of Emergency and Cardiovascular Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
Karl
K
Swedberg
Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
Adriaan A
AA
Voors
Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Randall C
RC
Starling
Division of Cardiology, University of California, San Francisco, San Francisco, California; San Francisco Veterans Affairs Medical Center, San Francisco, California.
John R
JR
Teerlink
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Christopher M
CM
O'Connor
D000208:Acute Disease; D000368:Aged; D002423:Cause of Death / Q000639:trends; D005260:Female; D014943:Global Health; D006333:Heart Failure / Q000453:epidemiology* / Q000628:therapy; D006760:Hospitalization / Q000639:trends*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment / Q000379:methods*; D015996:Survival Rate / Q000639:trends