Περίληψη:
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.
Συγγραφείς:
Zannad, Faiez
Garcia, Angeles Alonso
Anker, Stefan D. and
Armstrong, Paul W.
Calvo, Gonzalo
Cleland, John G. F.
Cohn,
Jay N.
Dickstein, Kenneth
Domanski, Michael J.
Ekman, Inger
and Filippatos, Gerasimos S.
Gheorghiade, Mihai
Hernandez,
Adrian F.
Jaarsma, Tiny
Koglin, Joerg
Konstam, Marvin and
Kupfer, Stuart
Maggioni, Aldo P.
Mebazaa, Alexandre
Metra,
Marco
Nowack, Christina
Pieske, Burkert
Pina, Ileana L. and
Pocock, Stuart J.
Ponikowski, Piotr
Rosano, Giuseppe and
Ruilope, Luis M.
Ruschitzka, Frank
Severin, Thomas
Solomon,
Scott
Stein, Kenneth
Stockbridge, Norman L.
Stough, Wendy
Gattis
Swedberg, Karl
Tavazzi, Luigi
Voors, Adriaan A. and
Wasserman, ScottM.
Woehrle, Holger
Zalewski, Andrew and
McMurray, John J. V.
