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Redefining the role of biomarkers in heart failure trials: expert consensus document

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Abstract

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.

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Authors and Affiliations

  1. BAYER AG, Experimental Medicine Cardiovascular/Hematology, Aprather Weg 18a, 42133, Wuppertal, Germany

    Frank Kramer & Wilfried Dinh

  2. Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI, 48202, USA

    Hani N. Sabbah

  3. Cardiology Division, Massachusetts General Hospital; Clinical Trial Design, Baim Institute for Clinical Research, Boston, MA, USA

    James J. Januzzi

  4. 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 Zannad

  5. Department of Clinical Genetics, University of Amsterdam, Academic Medical Center, Amsterdam, The Netherlands

    J. Peter van Tintelen

  6. UPMC Cardiovascular Magnetic Resonance Center, University of Pittsburgh, Pittsburgh, PA, USA

    Erik B. Schelbert

  7. Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC, USA

    Raymond J. Kim

  8. 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 Milting

  9. BAYER, Research & Clinical Sciences Statistics, Berlin, Germany

    Richardus Vonk

  10. Medtronic Diagnostics, 8200 Coral Sea Street, MVC43, Minneapolis, MN, 55112, USA

    Brien Neudeck & Richard Clark

  11. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK

    Klaus Witte

  12. Department of Internal Medicine and Cardiology, Charité University Medicine Berlin—Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany

    Burkert Pieske

  13. Department of Internal Medicine and Cardiology, German Heart Center Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Burkert Pieske

  14. Berlin Institute of Health, Kapelle-Ufer 2, 10117, Berlin, Germany

    Burkert Pieske

  15. Division of Cardiology, Health Sciences Center, SUNY, T-16 Room 080, Stony Brook, NY, 11794, USA

    Javed Butler

  16. Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 201 East Huron, Galter 3-150, Chicago, IL, 60611, USA

    Mihai Gheorghiade

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  1. Frank Kramer
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  2. Hani N. Sabbah
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Correspondence to Frank Kramer.

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Conflict of interest

F.K., W.D., and R.V. are full-time employees of BAYER AG.

H.N.S. has no conflicts to declare.

J.J. received grant support from Siemens, Singulex, and Prevencio and consulting income from Roche Diagnostics, Critical Diagnostics, Sphingotec, Bayer, Philips, and Novartis and participates in clinical endpoint committees/data safety monitoring boards for Novartis, Amgen, Janssen, and Boehringer Ingelheim and is supported in part by the Hutter Family Professorship Endowment in Cardiology at the Harvard Medical School.

F.Z. reports personal fees from Janssen, Bayer, Pfizer, Novartis, Boston Scientific, Resmed, Amgen, CVRx, Quantum Genomics, Eli Lilly, Takeda, and General Electric, outside the submitted work.

J.P.vT. has no conflicts to declare.

E.B.S. has no conflicts to declare.

H.M. supported by the Deutsche Forschungsgemeinschaft (DFG), the Deutsches Zentrum für Herz-Kreislauferkrankungen (DZHK), and the Erich & Hanna Klessmann-Foundation, Germany, and received fees and research funding from the Bayer AG, Germany.

J.S. and R.C. are full-time employees of MEDTRONIC Inc.

K.W. has no conflicts to declare.

B.P. received consulting income from Bayer Healthcare, Stealth Peptides, Novartis, Astra Zeneca, Daiichi Sankyo, and Vifor Pharma.

J.B. received research support from the National Institutes of Health, European Union, and Patient Centered Outcomes Research Institute and is a consultant to Amgen, Astra-Zeneca, Bayer, Boehringer Ingelheim, BMS, CVRx, Janssen, Medtronic, Novartis, Relypsa, and ZS Pharma.

M.G. received grant support from AbbVie Inc., AstraZeneca, Bayer Pharma AG, Cardiocell LLC, Cardiorentis Ltd., GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Novartis Pharma AG, Ono Pharmaceuticals USA, Otsuka Pharmaceuticals, Sanofi-Aventis, Sigma Tau, Solvay Pharmaceuticals, Stealth BioTherapeutics, Sticares InterACT, and Takeda Pharmaceuticals North America Inc.

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Kramer, F., Sabbah, H.N., Januzzi, J.J. et al. Redefining the role of biomarkers in heart failure trials: expert consensus document. Heart Fail Rev 22, 263–277 (2017). https://doi.org/10.1007/s10741-017-9608-5

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