Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

被引：57

作者：

Anker, Stefan D. ^{[1
,2
,3
]}

Butler, Javed ^{[4
]}

Khan, Muhammad Shahzeb ^{[5
]}

Abraham, William T. ^{[6
]}

Bauersachs, Johann ^{[7
]}

Bocchi, Edimar ^{[8
]}

Bozkurt, Biykem ^{[9
]}

Braunwald, Eugene ^{[10
]}

Chopra, Vijay K. ^{[11
]}

Cleland, John G. ^{[12
]}

Ezekowitz, Justin ^{[13
]}

Filippatos, Gerasimos ^{[14
]}

Friede, Tim ^{[15
,16
]}

Hernandez, Adrian F. ^{[17
]}

Lam, Carolyn S. P. ^{[18
,19
]}

Lindenfeld, JoAnn ^{[20
]}

McMurray, John J. V. ^{[21
]}

Mehra, Mandeep ^{[22
]}

Metra, Marco ^{[23
]}

Packer, Milton ^{[24
]}

Pieske, Burkert ^{[25
,26
,27
,28
]}

Pocock, Stuart J. ^{[29
]}

Ponikowski, Piotr ^{[30
]}

Rosano, Giuseppe M. C. ^{[31
,32
]}

Teerlink, John R. ^{[33
]}

Tsutsui, Hiroyuki ^{[34
]}

Van Veldhuisen, Dirk J. ^{[19
]}

Verma, Subodh ^{[35
]}

Voors, Adriaan A. ^{[19
]}

Wittes, Janet ^{[36
]}

Zannad, Faiez ^{[37
,38
]}

Zhang, Jian ^{[39
]}

Seferovic, Petar ^{[40
]}

Coats, Andrew J. S. ^{[41
]}

机构：

[1] Charite Univ Med Berlin, Dept Cardiol CVK, Berlin, Germany

[2] Charite Univ Med Berlin, Berlin Inst Hlth, Ctr Regenerat Therapies BCRT, Berlin, Germany

[3] Charite Univ Med Berlin, German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany

[4] Univ Mississippi, Med Ctr, Dept Med, Jackson, MS 39216 USA

[5] Cook Cty Hosp, Dept Med, Chicago, IL 60612 USA

[6] Ohio State Univ, Div Cardiovasc Med, Davis Heart & Lung Res Inst, Columbus, OH 43210 USA

[7] Hannover Med Sch, Dept Cardiol & Angiol, Hannover, Germany

[8] Univ Sao Paulo, Div Cardiol, Sch Med, Sao Paulo, Brazil

[9] Baylor Coll Med, Winters Ctr Heart Failure Res, Cardiovasc Res Inst, Michael E DeBakey VA Med Ctr, Houston, TX 77030 USA

[10] Harvard Med Sch, Brigham & Womens Hosp, Boston, MA 02115 USA

[11] Max Super Special Hosp, Dept Cardiol, New Delhi, India

[12] Univ Glasgow, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland

[13] Univ Alberta, Canadian VIGOUR Ctr, Edmonton, AB, Canada

[14] Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Athens, Greece

[15] Univ Med Ctr Goettingen, Dept Med Stat, Gottingen, Germany

[16] German Ctr Cardiovasc Res DZHK, Partner Site Goettingen, Gottingen, Germany

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

[18] Duke Natl Univ Singapore, Natl Heart Ctr Singapore, Singapore, Singapore

[19] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[20] Vanderbilt Heart & Vasc Inst, Nashville, TN USA

[21] Univ Glasgow, BHF Cardiovasc Res Ctr, Glasgow, Lanark, Scotland

[22] Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA

[23] Univ Brescia, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Cardiol, Brescia, Italy

[24] Baylor Univ, Med Ctr, Baylor Heart & Vasc Inst, Dallas, TX USA

[25] Charite Univ Med Berlin, Dept Internal Med & Cardiol, Campus Virchow Klinikum, Berlin, Germany

[26] German Heart Ctr Berlin, Dept Internal Med & Cardiol, Berlin, Germany

[27] German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany

[28] Berlin Inst Hlth BIH, Berlin, Germany

[29] London Sch Hyg & Trop Med, London, England

[30] Med Univ, Univ Hosp, Dept Heart Dis, Wroclaw, Poland

[31] IRCCS San Raffaele Pisana, Rome, Italy

[32] St Georges Med Sch, London, England

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

[34] Kyushu Univ, Grad Sch Med Sci, Dept Cardiovasc Med, Fukuoka, Japan

[35] Univ Toronto, St Michaels Hosp, Div Cardiac Surg, Toronto, ON, Canada

[36] Stat Collaborat Inc, Washington, DC USA

[37] Univ Lorraine, Ctr Invest Clin Plurithemat, CIC P 1433, INSERM, Nancy, France

[38] Univ Lorraine, CHRU Nancy Brabois, INSERM U1116, F CRIN INI CRCT, Nancy, France

[39] Fuwai Hosp, Natl Ctr Cardiovasc Dis, Heart Failure Ctr, Beijing, Peoples R China

[40] Univ Belgrade, Serbian Acad Sci & Arts, Fac Med, Belgrade, Serbia

[41] San Raffaele Pisana Sci Inst, Rome, Italy

来源：

EUROPEAN HEART JOURNAL | 2020年 / 41卷 / 22期

关键词：

Heart failure; Clinical trials; COVID-19; Coronavirus;

D O I：

10.1093/eurheartj/ehaa461

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

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