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

被引：14

作者：

Kramer, Frank ^{[1
]}

Sabbah, Hani N. ^{[2
]}

Januzzi, James J. ^{[3
]}

Zannad, Faiez ^{[4
,5
]}

van Tintelen, J. Peter ^{[6
]}

Schelbert, Erik B. ^{[7
]}

Kim, Raymond J. ^{[8
]}

Milting, Hendrik ^{[9
]}

Vonk, Richardus ^{[10
]}

Neudeck, Brien ^{[11
]}

Clark, Richard ^{[11
]}

Witte, Klaus ^{[12
]}

Dinh, Wilfried ^{[1
]}

Pieske, Burkert ^{[13
,14
,15
]}

Butler, Javed ^{[16
]}

Gheorghiade, Mihai ^{[17
]}

机构：

[1] Bayer AG, Expt Med Cardiovasc Hematol, Aprather Weg 18a, D-42133 Wuppertal, Germany

[2] Henry Ford Hosp, Div Cardiovasc Med, Dept Med, 2799 West Grand Blvd, Detroit, MI 48202 USA

[3] Massachusetts Gen Hosp, Cardiol Div, Baim Inst Clin Res, Clin Trial Design, Boston, MA 02114 USA

[4] Univ Lorraine, Inserm Clin Invest Ctr 1403, CHU Nancy, Inst Lorrain Coeur & Vaisseaux CHU, Nancy, France

[5] Univ Lorraine, Nancy, France

[6] Univ Amsterdam, Acad Med Ctr, Dept Clin Genet, Amsterdam, Netherlands

[7] Univ Pittsburgh, UPMC Cardiovasc Magnet Resonance Ctr, Pittsburgh, PA USA

[8] Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27710 USA

[9] Ruhr Univ, Univ Clin, Heart & Diabet Ctr NRW, Erich & Hanna Klessmann Inst Cardiovasc Res & Dev, Bad Oeynhausen, Germany

[10] BAYER, Res & Clin Sci Stat, Berlin, Germany

[11] Medtron Diagnost, 8200 Coral Sea St,MVC43, Minneapolis, MN 55112 USA

[12] Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England

[13] Charite, Campus Virchow Klinikum, Dept Internal Med & Cardiol, Augustenburger Pl 1, D-13353 Berlin, Germany

[14] German Heart Ctr Berlin, Dept Internal Med & Cardiol, Augustenburger Pl 1, D-13353 Berlin, Germany

[15] Berlin Inst Hlth, Kapelle Ufer 2, D-10117 Berlin, Germany

[16] SUNY Stony Brook, Hlth Sci Ctr, Div Cardiol, T-16 Room 080, Stony Brook, NY 11794 USA

[17] Northwestern Univ, Feinberg Sch Med, Ctr Cardiovasc Innovat, 201 East Huron,Galter 3-150, Chicago, IL 60611 USA

来源：

HEART FAILURE REVIEWS | 2017年 / 22卷 / 03期

基金：

美国国家卫生研究院;

关键词：

Heart failure; Biomarker; Drug development; Medical device; Imaging; Clinical trial; EXTRACELLULAR VOLUME FRACTION; CARDIOVASCULAR MAGNETIC-RESONANCE; IDIOPATHIC DILATED CARDIOMYOPATHY; RIGHT-VENTRICULAR CARDIOMYOPATHY; REDUCED EJECTION FRACTION; DIFFERENTIATION FACTOR 15; MYOCARDIAL FIBROSIS; DEVICE DIAGNOSTICS; HISTOLOGICAL VALIDATION; DIASTOLIC DYSFUNCTION;

D O I：

10.1007/s10741-017-9608-5

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：263 / 277

页数：15

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Raymond J. Kim
Hendrik Milting
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