• Stefan D Anker, Javed Butler, Muhammad Shahzeb Khan, William T Abraham, Johann Bauersachs, Edimar Bocchi, Biykem Bozkurt, Eugene Braunwald, Vijay K Chopra, John G Cleland, Justin Ezekowitz, Gerasimos Filippatos, Tim Friede, Adrian F Hernandez, Lam Carolyn S P CSP National Heart Centre Singapore, Duke-National University of Singapore, Singapore. D, JoAnn Lindenfeld, McMurray John J V JJV BHF Cardiovascular Research Center, University of Glasgow, Glasgow, UK., Mandeep Mehra, Marco Metra, Milton Packer, Burkert Pieske, Stuart J Pocock, Piotr Ponikowski, Rosano Giuseppe M C GMC IRCCS San Raffaele Pisana, Rome, Italy. St George's Medical School, London, UK., John R Teerlink, Hiroyuki Tsutsui, Dirk J Van Veldhuisen, Subodh Verma, Adriaan A Voors, Janet Wittes, Faiez Zannad, Jian Zhang, Petar Seferovic, and Coats Andrew J S AJS San Raffaele Pisana Scientific Institute, Rome, Italy..
• Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.
• Eur. Heart J. 2020 Jun 7; 41 (22): 2109-2117.

AbstractThe 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.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.

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