caa a22 4500 605478961 CHVBK 20210128100408.0 cr unu---uuuuu 210128e20150701xx s 000 0 eng 10.1007/s10741-015-9485-8 doi (NATIONALLICENCE)springer-10.1007/s10741-015-9485-8 Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations [Elektronische Daten] [Muthiah Vaduganathan, Javed Butler, Lothar Roessig, Gregg Fonarow, Stephen Greene, Marco Metra, Gadi Cotter, Stuart Kupfer, Andrew Zalewski, Naoki Sato, Gerasimos Filippatos, Mihai Gheorghiade] With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF? Springer Science+Business Media New York, 2015 Clinical trials nationallicence Heart failure nationallicence Outcomes nationallicence Patient selection nationallicence Vaduganathan Muthiah Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA aut Butler Javed Cardiology Division, Emory University Hospital, Atlanta, GA, USA aut Roessig Lothar Novartis Pharmaceutical Corporation, East Hanover, NJ, USA aut Fonarow Gregg Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, CA, USA aut Greene Stephen Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA aut Metra Marco Division of Cardiology, University of Brescia, Brescia, Italy aut Cotter Gadi Momentum-Research, Inc., Durham, NC, USA aut Kupfer Stuart Takeda Global Research and Development Center, Inc., Deerfield, IL, USA aut Zalewski Andrew Bayer Pharma AG, Berlin, Germany aut Sato Naoki Department of Internal Medicine and Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan aut Filippatos Gerasimos Attikon University Hospital, Athens, Greece aut Gheorghiade Mihai Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA aut Heart Failure Reviews Springer US; http://www.springer-ny.com 20/4(2015-07-01), 393-400 1382-4147 20:4<393 2015 20 10741 https://doi.org/10.1007/s10741-015-9485-8 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10741-015-9485-8 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Vaduganathan Muthiah Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA aut NATIONALLICENCE 700 1- Butler Javed Cardiology Division, Emory University Hospital, Atlanta, GA, USA aut NATIONALLICENCE 700 1- Roessig Lothar Novartis Pharmaceutical Corporation, East Hanover, NJ, USA aut NATIONALLICENCE 700 1- Fonarow Gregg Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, CA, USA aut NATIONALLICENCE 700 1- Greene Stephen Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA aut NATIONALLICENCE 700 1- Metra Marco Division of Cardiology, University of Brescia, Brescia, Italy aut NATIONALLICENCE 700 1- Cotter Gadi Momentum-Research, Inc., Durham, NC, USA aut NATIONALLICENCE 700 1- Kupfer Stuart Takeda Global Research and Development Center, Inc., Deerfield, IL, USA aut NATIONALLICENCE 700 1- Zalewski Andrew Bayer Pharma AG, Berlin, Germany aut NATIONALLICENCE 700 1- Sato Naoki Department of Internal Medicine and Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan aut NATIONALLICENCE 700 1- Filippatos Gerasimos Attikon University Hospital, Athens, Greece aut NATIONALLICENCE 700 1- Gheorghiade Mihai Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA aut NATIONALLICENCE 773 0- Heart Failure Reviews Springer US; http://www.springer-ny.com 20/4(2015-07-01), 393-400 1382-4147 20:4<393 2015 20 10741