Corticosteroid burst therapy in patients with acute heart failure: Design of the CORTAHF pilot study

Author:

Cotter Gad123,Davison Beth123,Freund Yonathan45,Mebazaa Alexandre16,Voors Adriaan7,Edwards Christopher3,Novosadova Maria3,Takagi Koji3ORCID,Hayrapetyan Hamlet8,Mshetsyan Andranik9,Mayranush Drambyan10,Cohen‐Solal Alain111,ter Maaten Jozine M.7,Biegus Jan12,Ponikowski Piotr12,Filippatos Gerasimos13,Chioncel Ovidiu14,Pagnesi Matteo15,Simon Tabassome416,Metra Marco15,Mann Douglas L.17

Affiliation:

1. Université Paris Cité, INSERM UMR‐S 942 (MASCOT) Paris France

2. Heart Initiative Durham NC USA

3. Momentum Research, Inc. Durham NC USA

4. IMProving Emergency Care FHU Sorbonne Université Paris France

5. Emergency Department and Service Mobile d'Urgence et de Réanimation (SMUR) Hôpital Pitié‐Salpêtrière, Assistance Publique‐Hôpitaux de Paris (AP‐HP) Paris France

6. Department of Anesthesiology and Critical Care and Burn Unit, Saint‐Louis and Lariboisière Hospitals FHU PROMICE, DMU Parabol, APHP Nord Paris France

7. Department of Cardiology University Medical Centre Groningen, University of Groningen Groningen The Netherlands

8. Erebouni Medical Center Yerevan Armenia

9. ‘Mikaelyan’ Surgery Institute CJSC Yerevan Armenia

10. ‘Armenia’ Medical Center Yerevan Armenia

11. Department of Cardiology, APHP Nord Lariboisière University Hospital Paris France

12. Institute of Heart Diseases Wroclaw Medical University Wroclawa Poland

13. National and Kapodistrian University of Athens, School of Medicine Attikon University Hospital Haidari Greece

14. Emergency Institute for Cardiovascular Diseases ‘Prof. C.C. Iliescu’ University of Medicine ‘Carol Davila’ Bucharest Romania

15. Department of Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health University of Brescia Brescia Italy

16. Department of Clinical Pharmacology and Clinical Research Platform Paris‐East (URCEST‐CRC‐CRB) St Antoine Hospital, APHP Paris France

17. Department of Medicine, Division of Cardiovascular, Center for Cardiovascular Research Washington University School of Medicine St. Louis MO USA

Abstract

AbstractAimsInflammation has emerged as a potential key pathophysiological mechanism in heart failure (HF) in general and acute HF (AHF) specifically, with inflammatory biomarkers shown to be highly predictive of adverse outcomes in these patients. The CORTAHF study builds on both these data and the fact that steroid burst therapy has been shown to be effective in the treatment of respiratory diseases and COVID‐19. Our hypothesis is that in patients with AHF and elevated C‐reactive protein (CRP) levels without symptoms or signs of infection, a 7‐day course of steroid therapy will lead to reduced inflammation and short‐term improvement in quality of life and a reduced risk of worsening HF (WHF) events.Methods and resultsThe study, which is currently ongoing, will include 100 patients with AHF ages 18–85, regardless of ejection fraction, screened within 12 h of presentation. Patients will be included who have NT‐proBNP > 1500 pg/mL and CRP > 20 mg/L at screening. Exclusion criteria include haemodynamic instability and symptoms and signs of infection. After signed consent, eligible patients will be randomized according to a central randomization scheme stratified by centre 1:1 to either treatment once daily for 7 days with 40 mg prednisone orally or to standard care. Patients will be assessed at study day 2, day 4 or at discharge if earlier, and at days 7 and 31 at the hospital; and at day 91 through a telephone follow‐up. The primary endpoint is the change in CRP level from baseline to day 7, estimated from a mixed model for repeated measures (MMRM) including all measured timepoints, in patients without a major protocol violation. Secondary endpoints include the time to the first event of WHF adverse event, readmission for HF, or death through day 91; and changes to day 7 in EQ‐5D visual analogue scale score and utility index. Additional clinical and laboratory measures will be assessed.ConclusionsThe results of the study will add to the knowledge of the role of inflammation in AHF and potentially inform the design of larger studies with possibly longer duration of anti‐inflammatory therapies in AHF.

Publisher

Wiley

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