Redefining the role of biomarkers in heart failure trials: expert consensus document.
Heart failure is a growing cardiovascular disease with significant epidemiological, clinical, and societal implications and represents a high unmet need. Strong efforts are currently underway by academic and industrial researchers to develop novel treatments for heart failure. Biomarkers play an important role in patient selection and monitoring in drug trials and in clinical management. The present review gives an overview of the role of available molecular, imaging, and device-derived digital biomarkers in heart failure drug development and highlights capabilities and limitations of biomarker use in this context.
BAYER AG, Experimental Medicine Cardiovascular/Hematology, Aprather Weg 18a, 42133, Wuppertal, Germany. frank.kramer@bayer.com.
Frank
0000-0001-7701-912X
F
Kramer
Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI, 48202, USA.
Hani N
HN
Sabbah
Cardiology Division, Massachusetts General Hospital; Clinical Trial Design, Baim Institute for Clinical Research, Boston, MA, USA.
James J
JJ
Januzzi
Inserm Clinical Investigation Center 1403, Université de Lorraine, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux CHU and University de Lorraine, Nancy, France.
Faiez
F
Zannad
Department of Clinical Genetics, University of Amsterdam, Academic Medical Center, Amsterdam, The Netherlands.
J
J
Peter van Tintelen
UPMC Cardiovascular Magnetic Resonance Center, University of Pittsburgh, Pittsburgh, PA, USA.
Erik B
EB
Schelbert
Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Raymond J
RJ
Kim
Heart and Diabetes Center NRW, University Clinics of the Ruhr University, Erich and Hanna Klessmann-Institute for Cardiovascular Research and Development, Bad Oeynhausen, Germany.
Hendrik
H
Milting
BAYER, Research & Clinical Sciences Statistics, Berlin, Germany.
Richardus
R
Vonk
Medtronic Diagnostics, 8200 Coral Sea Street, MVC43, Minneapolis, MN, 55112, USA.
Brien
B
Neudeck
Medtronic Diagnostics, 8200 Coral Sea Street, MVC43, Minneapolis, MN, 55112, USA.
Richard
R
Clark
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Klaus
K
Witte
BAYER AG, Experimental Medicine Cardiovascular/Hematology, Aprather Weg 18a, 42133, Wuppertal, Germany.
Wilfried
W
Dinh
Department of Internal Medicine and Cardiology, Charité University Medicine Berlin-Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.|Department of Internal Medicine and Cardiology, German Heart Center Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.|Berlin Institute of Health, Kapelle-Ufer 2, 10117, Berlin, Germany.
Burkert
B
Pieske
Division of Cardiology, Health Sciences Center, SUNY, T-16 Room 080, Stony Brook, NY, 11794, USA.
Javed
J
Butler
Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron, Galter 3-150, Chicago, IL, 60611, USA.
Mihai
M
Gheorghiade
D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic / Q000379:methods*; D032921:Consensus; D003952:Diagnostic Imaging / Q000379:methods*; D019468:Disease Management; D006333:Heart Failure / Q000097:blood / Q000175:diagnosis / Q000628:therapy; D006801:Humans; D018579:Patient Selection
D015415:Biomarkers
Biomarker; Clinical trial; Drug development; Heart failure; Imaging; Medical device