Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations
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| 024 | 7 | 0 | |a 10.1007/s10741-015-9485-8 |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10741-015-9485-8 | ||
| 245 | 0 | 0 | |a Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations |h [Elektronische Daten] |c [Muthiah Vaduganathan, Javed Butler, Lothar Roessig, Gregg Fonarow, Stephen Greene, Marco Metra, Gadi Cotter, Stuart Kupfer, Andrew Zalewski, Naoki Sato, Gerasimos Filippatos, Mihai Gheorghiade] |
| 520 | 3 | |a 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? | |
| 540 | |a Springer Science+Business Media New York, 2015 | ||
| 690 | 7 | |a Clinical trials |2 nationallicence | |
| 690 | 7 | |a Heart failure |2 nationallicence | |
| 690 | 7 | |a Outcomes |2 nationallicence | |
| 690 | 7 | |a Patient selection |2 nationallicence | |
| 700 | 1 | |a Vaduganathan |D Muthiah |u Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA |4 aut | |
| 700 | 1 | |a Butler |D Javed |u Cardiology Division, Emory University Hospital, Atlanta, GA, USA |4 aut | |
| 700 | 1 | |a Roessig |D Lothar |u Novartis Pharmaceutical Corporation, East Hanover, NJ, USA |4 aut | |
| 700 | 1 | |a Fonarow |D Gregg |u Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, CA, USA |4 aut | |
| 700 | 1 | |a Greene |D Stephen |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA |4 aut | |
| 700 | 1 | |a Metra |D Marco |u Division of Cardiology, University of Brescia, Brescia, Italy |4 aut | |
| 700 | 1 | |a Cotter |D Gadi |u Momentum-Research, Inc., Durham, NC, USA |4 aut | |
| 700 | 1 | |a Kupfer |D Stuart |u Takeda Global Research and Development Center, Inc., Deerfield, IL, USA |4 aut | |
| 700 | 1 | |a Zalewski |D Andrew |u Bayer Pharma AG, Berlin, Germany |4 aut | |
| 700 | 1 | |a Sato |D Naoki |u Department of Internal Medicine and Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan |4 aut | |
| 700 | 1 | |a Filippatos |D Gerasimos |u Attikon University Hospital, Athens, Greece |4 aut | |
| 700 | 1 | |a Gheorghiade |D Mihai |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA |4 aut | |
| 773 | 0 | |t Heart Failure Reviews |d Springer US; http://www.springer-ny.com |g 20/4(2015-07-01), 393-400 |x 1382-4147 |q 20:4<393 |1 2015 |2 20 |o 10741 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10741-015-9485-8 |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
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| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10741-015-9485-8 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Vaduganathan |D Muthiah |u Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Butler |D Javed |u Cardiology Division, Emory University Hospital, Atlanta, GA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Roessig |D Lothar |u Novartis Pharmaceutical Corporation, East Hanover, NJ, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Fonarow |D Gregg |u Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, CA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Greene |D Stephen |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Metra |D Marco |u Division of Cardiology, University of Brescia, Brescia, Italy |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Cotter |D Gadi |u Momentum-Research, Inc., Durham, NC, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kupfer |D Stuart |u Takeda Global Research and Development Center, Inc., Deerfield, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Zalewski |D Andrew |u Bayer Pharma AG, Berlin, Germany |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Sato |D Naoki |u Department of Internal Medicine and Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Filippatos |D Gerasimos |u Attikon University Hospital, Athens, Greece |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Gheorghiade |D Mihai |u Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron Street, Galter 3-150, 60611, Chicago, IL, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t Heart Failure Reviews |d Springer US; http://www.springer-ny.com |g 20/4(2015-07-01), 393-400 |x 1382-4147 |q 20:4<393 |1 2015 |2 20 |o 10741 | ||