TY - JOUR
T1 - Clinical outcome endpoints in heart failure trials
T2 - A European Society of Cardiology Heart Failure Association consensus document
AU - Zannad, Faiez
AU - Stein, Kenneth
AU - Garcia, Angeles Alonso
AU - Anker, Stefan D.
AU - Armstrong, Paul W.
AU - Calvo, Gonzalo
AU - Cleland, John G F
AU - Cohn, Jay N.
AU - Dickstein, Kenneth
AU - Domanski, Michael J.
AU - Ekman, Inger
AU - Filippatos, Gerasimos S.
AU - Gheorghiade, Mihai
AU - Hernandez, Adrian F.
AU - Jaarsma, Tiny
AU - Koglin, Joerg
AU - Konstam, Marvin
AU - Kupfer, Stuart
AU - Maggioni, Aldo P.
AU - Mebazaa, Alexandre
AU - Metra, Marco
AU - Nowack, Christina
AU - Pieske, Burkert
AU - Piña, Ileana L.
AU - Pocock, Stuart J.
AU - Ponikowski, Piotr
AU - Rosano, Giuseppe
AU - Ruilope, Luis M.
AU - Ruschitzka, Frank
AU - Severin, Thomas
AU - Solomon, Scott
AU - Stockbridge, Norman L.
AU - Stough, Wendy Gattis
AU - Swedberg, Karl
AU - Tavazzi, Luigi
AU - Voors, Adriaan A.
AU - Wasserman, Scott M.
AU - Woehrle, Holger
AU - Zalewski, Andrew
AU - McMurray, John J V
PY - 2013/10
Y1 - 2013/10
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Heart failure
KW - Morbidity
KW - Mortality
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U2 - 10.1093/eurjhf/hft095
DO - 10.1093/eurjhf/hft095
M3 - Review article
C2 - 23787718
AN - SCOPUS:84885025341
SN - 1388-9842
VL - 15
SP - 1082
EP - 1094
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 10
ER -