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Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document
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- Zannad, F. (author)
- Université de Lorraine, Nancy, France
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- Garcia, A. A. (author)
- European Medicines Agency, Madrid, Spain
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- 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
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- Calvo, G. (author)
- Hospital Clinic of Barcelona, Spain
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- Cleland, J. G. (author)
- Castle Hill Hospital, Kingston-upon-Hull, UK
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- Cohn, J. N. (author)
- University of Minnesota, Minneapolis, USA
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- Dickstein, K. (author)
- University of Bergen, Stavanger University Hospital, Norway
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- Domanski, M. J. (author)
- Mount Sinai School of Medicine, New York, USA,University of Brescia, Italy
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- 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
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- Filippatos, G. S. (author)
- Athens University Hospital Attikon, Greece
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- Gheorghiade, M. (author)
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
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- Hernandez, A. F. (author)
- Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA
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- Jaarsma, Tiny (author)
- Linköpings universitet,Hälsa, Aktivitet, Vård (HAV),Hälsouniversitetet
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- Koglin, J. (author)
- Merck, Sharpe & Dohme Corporation, Whitehouse Station, NJ, USA
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- Konstam, M. (author)
- Tufts University, Boston, MA, USA
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- Kupfer, S. (author)
- Takeda Pharmaceuticals, Deerfield, IL, USA
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- Maggioni, A. P. (author)
- ANMCO Research Center, Florence, Italy
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- Mebazaa, A. (author)
- Hopital Lariboisiere, Paris, France
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- Metra, M. (author)
- Hospital 12 de Octubre, Madrid, Spain,Amgen Inc., Thousand Oaks, CA, USA
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- Nowack, C. (author)
- Bayer Pharma AG, Wuppertal, Germany
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- Pieske, B. (author)
- Medical University of Graz, Austria
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- Pina, I. L. (author)
- Montefiore Medical Center, Bronx, NY, USA
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- Pocock, S. J. (author)
- London School of Hygiene and Tropical Medicine, UK
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Ponikowski, P. (author)
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- Rosano, G. (author)
- IRCCS San Raffaele Hospital, Rome, Italy
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Ruilope, L. M. (author)
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- Ruschitzka, F. (author)
- University Hospital Zurich, Switzerland
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- Severin, T. (author)
- Novartis Pharma AG, Basel, Switzerland
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Solomon, S. (author)
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- Stein, K. (author)
- Boston Scientific Corporation, St. Paul, MN, USA
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- Stockbridge, N. L. (author)
- Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
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- Stough, W. G. (author)
- Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA
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- Swedberg, Karl, 1944 (author)
- Sahgrenska University, Hospital/Östra, Göteborg, Sweden
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- Tavazzi, L. (author)
- Villa Maria Cecilia Hospital, Cotignola, Italy
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- Voors, A. A. (author)
- University Medical Center, Groningen, The Netherlands
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Wasserman, S. M. (author)
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- Woehrle, H. (author)
- ResMed, Ulm, Germany
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- Zalewski, A. (author)
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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- McMurray, J. J. (author)
- University of Glasgow, UK
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(creator_code:org_t)
- 2014-01-27
- 2013
- English.
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In: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 15:10, s. 1082-1094
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Abstract
Subject headings
Close
- 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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To the university's database
- By the author/editor
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Zannad, F.
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Garcia, A. A.
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Anker, S. D.
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Armstrong, P. W.
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Calvo, G.
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Cleland, J. G.
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show more...
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Cohn, J. N.
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Dickstein, K.
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Domanski, M. J.
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Ekman, Inger, 19 ...
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Filippatos, G. S ...
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Gheorghiade, M.
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Hernandez, A. F.
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Jaarsma, Tiny
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Koglin, J.
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Konstam, M.
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Kupfer, S.
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Maggioni, A. P.
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Mebazaa, A.
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Metra, M.
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Nowack, C.
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Pieske, B.
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Pina, I. L.
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Pocock, S. J.
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Ponikowski, P.
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Rosano, G.
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Ruilope, L. M.
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Ruschitzka, F.
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Severin, T.
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Solomon, S.
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Stein, K.
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Stockbridge, N. ...
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Stough, W. G.
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Swedberg, Karl, ...
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Tavazzi, L.
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Voors, A. A.
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Wasserman, S. M.
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Woehrle, H.
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Zalewski, A.
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McMurray, J. J.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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European Journal ...
- By the university
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University of Gothenburg
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Linköping University