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Am J Cardiol. 2016 Jun 1;117(11):1771-8. doi: 10.1016/j.amjcard.2016.03.002. Epub 2016 Mar 19.

Geographic Differences in Patients in a Global Acute Heart Failure Clinical Trial (from the ASCEND-HF Trial).

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Division of Cardiology, Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy. Electronic address:
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.
Servi├žo de Cardiologia, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.
Cardiovascular Division, Pontificia Universidad Catolica deChile, Santiago, Chile.
Advocate Heart Institute, Naperville, Illinois.
Cardiology Division, Stavenger University Hospital, University of Bergen, Bergen, Norway.
Heart and Vascular Center, Metrohealth Medical Center, Cleveland, Ohio.
Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.
Pitie Salpetriere Hospital, University Pierre Marie Curie, Paris, France.
Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Australia.
Division of Cardiology, Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy.
Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, California.
BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
Heart and Lung Center, Meilahti Hospital, Helsinki, Finland.
Department of Emergency and Cardiovascular Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
Division of Cardiology, University of California, San Francisco, San Francisco, California; San Francisco Veterans Affairs Medical Center, San Francisco, California.


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.

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