Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium

被引：59

作者：

Abraham, William T. ^{[1
]}

Psotka, Mitchell A. ^{[2
]}

Fiuzat, Mona ^{[3
,4
]}

Filippatos, Gerasimos ^{[5
]}

Lindenfeld, JoAnn ^{[6
]}

Mehran, Roxana ^{[7
]}

Ambardekar, Amrut V. ^{[8
]}

Carson, Peter E. ^{[9
]}

Jacob, Richard ^{[10
]}

Januzzi, James L., Jr. ^{[10
]}

Konstam, Marvin A. ^{[11
]}

Krucoff, Mitchell W. ^{[3
,4
]}

Lewis, Eldrin F. ^{[12
]}

Piccini, Jonathan P. ^{[3
,4
]}

Solomon, Scott D. ^{[13
]}

Stockbridge, Norman ^{[14
]}

Teerlink, John R. ^{[15
,16
]}

Unger, Ellis F. ^{[13
]}

Zeitler, Emily P. ^{[17
,18
]}

Anker, Stefan D. ^{[19
]}

O'Connor, Christopher M. ^{[2
,3
,4
]}

机构：

[1] Ohio State Univ, Div Cardiovasc Med, 473 West 12th Ave,Room 200, Columbus, OH 43210 USA

[2] Inova Heart & Vasc Inst, Falls Church, VA USA

[3] Duke Univ, Med Ctr, Durham, NC USA

[4] Duke Clin Res Inst, Durham, NC USA

[5] Univ Cyprus, Sch Med, Shakolas Educ Ctr Clin Med, Nicosia, Cyprus

[6] Vanderbilt Heart & Vasc Inst, Heart Failure & Transplantat Sect, Nashville, TN USA

[7] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA

[8] Univ Colorado, Div Cardiol, Aurora, CO USA

[9] Washington Vet Affairs Med Ctr, Dept Cardiol, Washington, DC USA

[10] Massachusetts Gen Hosp, Div Cardiol, Cardiometab Trials, Baim Inst Clin Res, Boston, MA 02114 USA

[11] Tufts Med Ctr, CardioVasc Ctr, Boston, MA 02111 USA

[12] Stanford Univ, Div Cardiovasc Med, Palo Alto, CA 94304 USA

[13] Brigham & Womens Hosp, Div Cardiovasc, 75 Francis St, Boston, MA 02115 USA

[14] US FDA, Silver Spring, MD USA

[15] Univ Calif San Francisco, Cardiol Sect, San Francisco Vet Affairs Med Ctr, San Francisco, CA 94143 USA

[16] Univ Calif San Francisco, Sch Med, San Francisco, CA USA

[17] Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA

[18] Dartmouth Inst, Lebanon, NH USA

[19] Charite Univ Med Berlin, German Ctr Cardiovasc Res Partner Site Berlin, Berlin Brandenburg Ctr Regenerat Therapies, Div Cardiol & Metab,Dept Cardiol, Berlin, Germany

来源：

JACC-HEART FAILURE | 2020年 / 8卷 / 12期

基金：

美国国家卫生研究院;

关键词：

Heart failure; Clinical trial; Endpoints; Definitions; END-POINT DEFINITIONS; PRESERVED EJECTION FRACTION; TRIAL DESIGN PRINCIPLES; ASSOCIATION TASK-FORCE; MITRAL-VALVE REPAIR; AMERICAN-COLLEGE; ATRIAL-FIBRILLATION; CONSENSUS DOCUMENT; DEATH; MORTALITY;

D O I：

10.1016/j.jchf.2020.10.002

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation. (C) 2020 European Society of Cardiology and American College of Cardiology

引用

页码：961 / 972

页数：12

共 64 条

[1]

[Anonymous], 2013, KIDNEY INT SUPPL, DOI [DOI 10.1038/kisup.2012.77, 10.1097/PR9.0000000000001023]

[2]

[Anonymous], 2016, Fact Sheet

[3]

Heart Failure With Recovered Ejection Fraction Clinical Description, Biomarkers, and Outcomes [J].

Basuray, Anupam ;

French, Benjamin ;

Ky, Bonnie ;

Vorovich, Esther ;

Olt, Caroline ;

Sweitzer, Nancy K. ;

Cappola, Thomas P. ;

Fang, James C. .

CIRCULATION, 2014, 129 (23) :2380-2387

[4]

Association of Prior Left Ventricular Ejection Fraction With Clinical Outcomes in Patients With Heart Failure With Midrange Ejection Fraction [J].

Brann, Alison ;

Janvanishstaporn, Satit ;

Greenberg, Barry .

JAMA CARDIOLOGY, 2020, 5 (09) :1027-1035

[5]

Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure [J].

Bristow, MR ;

Gilbert, EM ;

Abraham, WT ;

Adams, KF ;

Fowler, MB ;

Hershberger, RE ;

Kubo, SH ;

Narahara, KA ;

Ingersoll, H ;

Krueger, S ;

Young, S ;

Shusterman, N .

CIRCULATION, 1996, 94 (11) :2807-2816

[6]

Calkins H, 2017, HEART RHYTHM, V14, pE445, DOI [10.1016/j.hrthm.2017.07.009, 10.1093/europace/eux275, 10.1016/j.hrthm.2017.05.012]

[7]

Mode of death in advanced heart failure - The Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure (COMPANION) trial [J].

Carson, P ;

Anand, I ;

O'Connor, C ;

Jaski, B ;

Steinberg, J ;

Lwin, A ;

Lindenfeld, J ;

Ghali, J ;

Barnet, JH ;

Feldman, AM ;

Bristow, MR .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2005, 46 (12) :2329-2334

[8]

The Hospitalization Burden and Post-Hospitalization Mortality Risk in Heart Failure With Preserved Ejection Fraction Results From the I-PRESERVE Trial (Irbesartan in Heart Failure and Preserved Ejection Fraction) [J].

Carson, Peter E. ;

Anand, Inder S. ;

Win, Sithu ;

Rector, Thomas ;

Haass, Markus ;

Lopez-Sendon, Jose ;

Miller, Alan ;

Teerlink, John R. ;

White, Michel ;

McKelvie, Robert S. ;

Komajda, Michel ;

Zile, Michael R. ;

McMurray, John J. ;

Massie, Barry .

JACC-HEART FAILURE, 2015, 3 (06) :429-441

[9]

The perindopril in elderly people with chronic heart failure (PEP-CHF) study [J].

Cleland, John G. F. ;

Tendera, Michal ;

Adamus, Jerzy ;

Freemantle, Nick ;

Polonski, Lech ;

Taylor, Jacqueline .

EUROPEAN HEART JOURNAL, 2006, 27 (19) :2338-2345

[10]

Clinical Data Interchange Standards Consortium, 2014, CARD STUD THER AR US

← 1 2 3 4 5 6 7 →