Evidence map›Paper›PMID 32498081›Full record

GuidelineEuropean heart journal2020

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).

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 and 24 more

Erratum issuedOpen access · bronzeAbstract readConsensus StatementPractice Guideline
In one paragraph

Guideline in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Efficacy and safety of intravenous iron repletion in patients with heart failure: a systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Pooled it
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  4. Trial
  5. Trial
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  8. Article
  9. Management of Cardiac Rhythm Disorders in Cardio-oncology.Arrhythmia & electrophysiology review · 2025
    Review
  10. Article
  11. Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  12. Review
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  14. One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape.Cardiovascular revascularization medicine : including molecular interventions · 2022
    Article
  15. Article
  16. Article
  17. Lessons learned from the pandemic that can be translated in the future.International journal of cardiology. Heart & vasculature · 2022
    Article
  18. Review
  19. On the role of data, statistics and decisions in a pandemic.Advances in statistical analysis : AStA : a journal of the German Statistical Society · 2022
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors at 20 institutions in 15 countries.

Stefan D AnkerDepartment 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.
Javed ButlerDepartment of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.
Muhammad Shahzeb KhanDepartment of Medicine, Cook County Hospital, Chicago, IL, USA.
William T AbrahamDivision of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus, OH, USA.
Johann BauersachsDepartment of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
Edimar BocchiDivision of Cardiology, Sâo Paulo University Medical School, São Paulo, Brazil.
Biykem BozkurtWinters Center for Heart Failure Research, Cardiovascular Research Institute, Baylor College of Medicine, Michael E. DeBakey VA Medical Center, Houston, TX, USA.
Eugene BraunwaldBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Vijay K ChopraDepartment of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.
John G ClelandRobertson Centre for Biostatistics & Clinical Trials, University of Glasgow, Lanarkshire, UK.
Justin EzekowitzCanadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Gerasimos FilippatosNational and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.
Tim FriedeDepartment of Medical Statistics, University Medical Center Goettingen; and German Centre for Cardiovascular Research (DZHK), partner site Goettingen, Goettingen, Germany.
Adrian F HernandezDivision of Cardiology, Duke University Medical Center, Durham, NC, USA.
Carolyn S P LamNational Heart Centre Singapore, Duke-National University of Singapore, Singapore.
JoAnn LindenfeldVanderbilt Heart and Vascular Institute, Nashville, TN, USA.
John J V McMurrayBHF Cardiovascular Research Center, University of Glasgow, Glasgow, UK.
Mandeep MehraHeart and Vascular Center, Brigham and Women's Hospital, Boston, MA, USA.
Marco MetraCardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Milton PackerBaylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.
Burkert PieskeDepartment of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.
Stuart J PocockLondon School of Hygiene and Tropical Medicine, London, UK.
Piotr PonikowskiDepartment of Heart Disease, University Hospital, Medical University, Wrocław, Poland.
Giuseppe M C RosanoIRCCS San Raffaele Pisana, Rome, Italy.
John R TeerlinkSection of Cardiology, San Francisco Veterans Affairs Medical Center, School of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Hiroyuki TsutsuiDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Dirk J Van VeldhuisenDepartment of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Subodh VermaDivision of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Canada.
Adriaan A VoorsDepartment of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Janet WittesStatistics Collaborative, Inc., Washington, DC, USA.
Faiez ZannadCentre d'Investigation Clinique-Plurithématique INSERM CIC-P 1433, and INSERM U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT, Université de Lorraine, Nancy, France.
Jian ZhangHeart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
Petar SeferovicUniversity of Belgrade Faculty of Medicine; Serbian Academy of Sciences and Arts, Belgrade, Serbia.
Andrew J S CoatsSan Raffaele Pisana Scientific Institute, Rome, Italy.
University Medical Center Groningen · NLBrigham and Women's Hospital · USUniversity of Glasgow · GBBaylor University Medical Center · USChinese Academy of Medical Sciences & Peking Union Medical College · CNDeutsches Herzzentrum der Charité · DEDuke Medical Center · USGerman Centre for Cardiovascular Research · DEInserm · FRIRCCS Ospedale San Raffaele · ITJackson Memorial Hospital · USJohn H. Stroger, Jr. Hospital of Cook County · USKyushu University · JPLondon School of Hygiene & Tropical Medicine · GBMax Super Speciality Hospital · INMedizinische Hochschule Hannover · DEMichael E. DeBakey VA Medical Center · USNational and Kapodistrian University of Athens · GRSan Francisco VA Medical Center · USSan Raffaele University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

BetacoronavirusCoronavirus InfectionsHeart FailurePandemicsPneumonia, ViralClinical Trials as TopicCOVID-19EuropeHumansInformed ConsentPatient SafetyPatient SelectionResearch DesignSARS-CoV-2Clinical trialsCoronavirusCOVID-19Heart failure

Identifiers

PMID32498081
PMCPMC7314099
OpenAlexW3033074701

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.