Clinical Outcome Endpoints in Heart Failure Trials: A European Society of Cardiology Heart Failure Association Consensus Document
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- Faiez Zannad
- INSERM, Centre d’Investigation Clinique 9501 and Unité 961, Centre Hospitalier Universitaire, and the Department of Cardiology, Nancy University, Université de Lorraine , Nancy ,
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- Angeles Alonso Garcia
- Scientific Advice Working Party European Medicines Agency , Madrid ,
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- Stefan D. Anker
- Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum , Berlin ,
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- Paul W. Armstrong
- University of Alberta , Edmonton ,
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- Gonzalo Calvo
- Hospital Clinic of Barcelona , Barcelona ,
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- John G.F. Cleland
- Department of Cardiology, Castle Hill Hospital , Kingston-upon-Hull ,
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- Jay N. Cohn
- Cardiovascular Division, University of Minnesota , Minneapolis, MN ,
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- Kenneth Dickstein
- University of Bergen, Stavanger University Hospital
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- Michael J. Domanski
- Cardiovascular Institute, Mount Sinai School of Medicine , New York, NY ,
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- Inger Ekman
- Sahlgrenska Academy, Gothenburg University; Centre for Person Centred Care Research (GPCC) , Gothenburg ,
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- Gerasimos S. Filippatos
- Athens University Hospital Attikon , Athens ,
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- Mihai Gheorghiade
- Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine , Chicago, IL ,
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- Adrian F. Hernandez
- Duke University Medical Center and Duke Clinical Research Institute , Durham, NC ,
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- Tiny Jaarsma
- Department of Social and Welfare Studies, University of Linkoping
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- Joerg Koglin
- Merck, Sharpe & Dohme Corporation , Whitehouse Station, NJ ,
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- Marvin Konstam
- Department of Cardiology, New England Medical Center, Tufts University , Boston, MA ,
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- Stuart Kupfer
- Takeda Pharmaceuticals , Deerfield, IL ,
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- Aldo P. Maggioni
- ANMCO Research Center , Florence ,
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- Alexandre Mebazaa
- Department of Anesthesia, Hopital Lariboisiere , Paris ,
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- Marco Metra
- Cardiology, University of Brescia , Brescia ,
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- Christina Nowack
- Bayer Pharma AG , Wuppertal ,
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- Burkert Pieske
- Department of Cardiology, Medical University of Graz , Graz ,
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- Ileana L. Piña
- Department of Medicine, Division of Cardiology, Montefiore Medical Center , Bronx, NY ,
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- Stuart J. Pocock
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine , London ,
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- Piotr Ponikowski
- Medical University, Military Hospital , Wroclaw ,
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- Giuseppe Rosano
- Department of Medical Sciences, IRCCS San Raffaele Hospital , Rome ,
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- Luis M. Ruilope
- Hypertension Unit , Hospital 12 de Octubre, Madrid ,
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- Frank Ruschitzka
- University Hospital Zurich , Zurich ,
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- Thomas Severin
- Novartis Pharma AG , Basel ,
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- Scott Solomon
- Cardiovascular Division, Brigham and Women’s Hospital , Boston, MA ,
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- Kenneth Stein
- Boston Scientific Corporation , St. Paul, MN ,
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- Norman L. Stockbridge
- Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration , Rockville, MD ,
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- Wendy Gattis Stough
- Campbell University College of Pharmacy and Health Sciences , Buies Creek, NC ,
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- Karl Swedberg
- Sahlgrenska University, Hospital/Östra , Göteborg ,
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- Luigi Tavazzi
- GVM Hospitals of Care and Research, Villa Maria Cecilia Hospital , Cotignola ,
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- Adriaan A. Voors
- Thoraxcenter, Department of Cardiology, University Medical Center, Groningen , Groningen ,
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- Scott M. Wasserman
- Amgen, Inc. , Thousand Oaks, CA ,
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- Holger Woehrle
- ResMed , Ulm ,
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- Andrew Zalewski
- Novartis Pharmaceuticals Corporation , East Hanover, NJ ,
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- John J.V. McMurray
- Western Infirmary and the British Heart Foundation, Glasgow Cardiovascular Research Centre, University of Glasgow , Glasgow ,
書誌事項
- 公開日
- 2013-10-01
- 権利情報
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- https://academic.oup.com/pages/standard-publication-reuse-rights
- DOI
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- 10.1093/eurjhf/hft095
- 公開者
- Oxford University Press (OUP)
この論文をさがす
説明
<jats:title>Abstract</jats:title> <jats:p>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.</jats:p>
収録刊行物
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- European Journal of Heart Failure
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European Journal of Heart Failure 15 (10), 1082-1094, 2013-10-01
Oxford University Press (OUP)