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Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document

Zannad, F. (author)
Université de Lorraine, Nancy, France
Garcia, A. A. (author)
European Medicines Agency, Madrid, Spain
Anker, S. D. (author)
Charité Medical School, Berlin, Germany,Brigham and Women's Hospital, Boston, MA, USA
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Armstrong, P. W. (author)
University of Alberta, Edmonton, Canada,Medical University, Military Hospital, Wroclaw, Poland
Calvo, G. (author)
Hospital Clinic of Barcelona, Spain
Cleland, J. G. (author)
Castle Hill Hospital, Kingston-upon-Hull, UK
Cohn, J. N. (author)
University of Minnesota, Minneapolis, USA
Dickstein, K. (author)
University of Bergen, Stavanger University Hospital, Norway
Domanski, M. J. (author)
Mount Sinai School of Medicine, New York, USA,University of Brescia, Italy
Ekman, Inger, 1952 (author)
Gothenburg University,Göteborgs universitet,Centrum för personcentrerad vård vid Göteborgs universitet (GPCC),University of Gothenburg Centre for person-centred care (GPCC),Sahlgrenska Academy, Gothenburg University, Sweden
Filippatos, G. S. (author)
Athens University Hospital Attikon, Greece
Gheorghiade, M. (author)
Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Hernandez, A. F. (author)
Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA
Jaarsma, Tiny (author)
Linköpings universitet,Hälsa, Aktivitet, Vård (HAV),Hälsouniversitetet
Koglin, J. (author)
Merck, Sharpe & Dohme Corporation, Whitehouse Station, NJ, USA
Konstam, M. (author)
Tufts University, Boston, MA, USA
Kupfer, S. (author)
Takeda Pharmaceuticals, Deerfield, IL, USA
Maggioni, A. P. (author)
ANMCO Research Center, Florence, Italy
Mebazaa, A. (author)
Hopital Lariboisiere, Paris, France
Metra, M. (author)
Hospital 12 de Octubre, Madrid, Spain,Amgen Inc., Thousand Oaks, CA, USA
Nowack, C. (author)
Bayer Pharma AG, Wuppertal, Germany
Pieske, B. (author)
Medical University of Graz, Austria
Pina, I. L. (author)
Montefiore Medical Center, Bronx, NY, USA
Pocock, S. J. (author)
London School of Hygiene and Tropical Medicine, UK
Ponikowski, P. (author)
Rosano, G. (author)
IRCCS San Raffaele Hospital, Rome, Italy
Ruilope, L. M. (author)
Ruschitzka, F. (author)
University Hospital Zurich, Switzerland
Severin, T. (author)
Novartis Pharma AG, Basel, Switzerland
Solomon, S. (author)
Stein, K. (author)
Boston Scientific Corporation, St. Paul, MN, USA
Stockbridge, N. L. (author)
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Stough, W. G. (author)
Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA
Swedberg, Karl, 1944 (author)
Sahgrenska University, Hospital/Östra, Göteborg, Sweden
Tavazzi, L. (author)
Villa Maria Cecilia Hospital, Cotignola, Italy
Voors, A. A. (author)
University Medical Center, Groningen, The Netherlands
Wasserman, S. M. (author)
Woehrle, H. (author)
ResMed, Ulm, Germany
Zalewski, A. (author)
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
McMurray, J. J. (author)
University of Glasgow, UK
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 (creator_code:org_t)
2014-01-27
2013
English.
In: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 15:10, s. 1082-1094
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g. all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12-13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Keyword

Heart failure
Morbidity
Mortality
Clinical trials
Heart failure

Publication and Content Type

ref (subject category)
art (subject category)

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