TY - JOUR
TI - Clinical outcome endpoints in heart failure trials: a European Society
of Cardiology Heart Failure Association consensus document
AU - Zannad, Faiez
AU - Garcia, Angeles Alonso
AU - Anker, Stefan D. and
AU - Armstrong, Paul W.
AU - Calvo, Gonzalo
AU - Cleland, John G. F.
AU - Cohn,
AU - Jay N.
AU - Dickstein, Kenneth
AU - Domanski, Michael J.
AU - Ekman, Inger
AU - and Filippatos, Gerasimos S.
AU - Gheorghiade, Mihai
AU - Hernandez,
AU - Adrian F.
AU - Jaarsma, Tiny
AU - Koglin, Joerg
AU - Konstam, Marvin and
AU - Kupfer, Stuart
AU - Maggioni, Aldo P.
AU - Mebazaa, Alexandre
AU - Metra,
AU - Marco
AU - Nowack, Christina
AU - Pieske, Burkert
AU - Pina, Ileana L. and
AU - Pocock, Stuart J.
AU - Ponikowski, Piotr
AU - Rosano, Giuseppe and
AU - Ruilope, Luis M.
AU - Ruschitzka, Frank
AU - Severin, Thomas
AU - Solomon,
AU - Scott
AU - Stein, Kenneth
AU - Stockbridge, Norman L.
AU - Stough, Wendy
AU - Gattis
AU - Swedberg, Karl
AU - Tavazzi, Luigi
AU - Voors, Adriaan A. and
AU - Wasserman, ScottM.
AU - Woehrle, Holger
AU - Zalewski, Andrew and
AU - McMurray, John J. V.
JO - European Journal of Heart Failure
PY - 2013
VL - 15
TODO - 10
SP - 1082-1094
PB - Oxford University Press
SN - null
TODO - 10.1093/eurjhf/hft095
TODO - Heart failure; Morbidity; Mortality; Clinical trials
TODO - 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, 1213
February 2012) to evaluate the challenges of defining heart failure
endpoints in clinical trials and to develop a consensus framework. This
report summarizes the groups recommendations for achieving common views
on heart failure endpoints in clinical trials.
ER -