@article{3158958,
    title = "Clinical outcome endpoints in heart failure trials: a European Society
of Cardiology Heart Failure Association consensus document",
    author = "Zannad, Faiez and Garcia, Angeles Alonso and Anker, Stefan D. and and Armstrong, Paul W. and Calvo, Gonzalo and Cleland, John G. F. and Cohn, and Jay N. and Dickstein, Kenneth and Domanski, Michael J. and Ekman, Inger and and Filippatos, Gerasimos S. and Gheorghiade, Mihai and Hernandez, and Adrian F. and Jaarsma, Tiny and Koglin, Joerg and Konstam, Marvin and and Kupfer, Stuart and Maggioni, Aldo P. and Mebazaa, Alexandre and Metra, and Marco and Nowack, Christina and Pieske, Burkert and Pina, Ileana L. and and Pocock, Stuart J. and Ponikowski, Piotr and Rosano, Giuseppe and and Ruilope, Luis M. and Ruschitzka, Frank and Severin, Thomas and Solomon, and Scott and Stein, Kenneth and Stockbridge, Norman L. and Stough, Wendy and Gattis and Swedberg, Karl and Tavazzi, Luigi and Voors, Adriaan A. and and Wasserman, ScottM. and Woehrle, Holger and Zalewski, Andrew and and McMurray, John J. V.",
    journal = "European Journal of Heart Failure",
    year = "2013",
    volume = "15",
    number = "10",
    pages = "1082-1094",
    publisher = "Oxford University Press",
    doi = "10.1093/eurjhf/hft095",
    keywords = "Heart failure; Morbidity; Mortality; Clinical trials",
    abstract = "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."
}