Burst steroid therapy for acute heart failure: The CORTAHF randomized, open-label, pilot trial.

Autor: Cotter G; Université Paris Cité, INSERM UMR-S 942 (MASCOT), Paris, France.; Heart Initiative, Durham, NC, USA.; Momentum Research, Inc, Durham, NC, USA., Davison BA; Université Paris Cité, INSERM UMR-S 942 (MASCOT), Paris, France.; Heart Initiative, Durham, NC, USA.; Momentum Research, Inc, Durham, NC, USA., Freund Y; IMProving Emergency Care FHU, Sorbonne Université, Paris, France.; Emergency Department and Service Mobile d'Urgence et de Réanimation (SMUR), Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France., Voors AA; University of Groningen, Department of Cardiology, University Medical Centre Groningen, Groningen, The Netherlands., Edwards C; Momentum Research, Inc, Durham, NC, USA., Novosadova M; Momentum Research, Inc, Durham, NC, USA., Takagi K; Momentum Research, Inc, Durham, NC, USA., Hayrapetyan H; Erebouni Medical Center, Yerevan, Armenia., Mshetsyan A; 'Mikaelyan' Surgery Institute CJSC, Yerevan, Armenia., Mayranush D; 'Armenia' Medical Center, Yerevan, Armenia., Cohen-Solal A; Université Paris Cité, INSERM UMR-S 942 (MASCOT), Paris, France.; Department of Cardiology, APHP Nord, Lariboisière University Hospital, Paris, France., Ter Maaten JM; University of Groningen, Department of Cardiology, University Medical Centre Groningen, Groningen, The Netherlands., Biegus J; Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland., Ponikowski P; Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland., Filippatos G; National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece., Chioncel O; Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine 'Carol Davila', Bucharest, Romania., Sadoune M; Université Paris Cité, INSERM UMR-S 942 (MASCOT), Paris, France., Pagnesi M; Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy., Simon T; IMProving Emergency Care FHU, Sorbonne Université, Paris, France., Metra M; Department of Clinical Pharmacology and Clinical Research Platform Paris-East (URCEST-CRC-CRB), St Antoine Hospital, APHP, Paris, France., Mann DL; Cardiovascular Division, Department of Medicine, Center for Cardiovascular Research, Washington University School of Medicine, St. Louis, MO, USA., Mebazaa A; Université Paris Cité, INSERM UMR-S 942 (MASCOT), Paris, France.; Department of Anesthesiology and Critical Care and Burn Unit, Saint-Louis and Lariboisière Hospitals, FHU PROMICE, DMU Parabol, APHP Nord, Paris, France.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2024 Oct; Vol. 26 (10), pp. 2282-2292. Date of Electronic Publication: 2024 Aug 30.
DOI: 10.1002/ejhf.3452
Abstrakt: Aims: Burst steroid therapy, effective in acute respiratory diseases, may benefit patients with acute heart failure (AHF) in whom inflammatory activation is associated with adverse outcomes.
Methods and Results: CORTAHF assessed whether burst steroid therapy reduces inflammation and results in better quality of life and clinical outcomes in AHF. Patients with AHF, N-terminal pro-B-type natriuretic peptide >1500 pg/ml, and high-sensitivity C-reactive protein (hsCRP) >20 mg/L were randomized 1:1 to oral, once daily 40 mg prednisone for 7 days or usual care, without blinding. Patients were followed for 90 days. A total of 101 patients were randomized. At day 7 the primary endpoint, hsCRP decreased in both arms - adjusted geometric mean ratios (GMRs) were 0.30 and 0.40 in the prednisone and usual care arms (ratio of GMRs 0.75, 95% confidence interval [CI] 0.56-1.00, p = 0.0498). The 90-day risk of worsening heart failure (HF), HF readmission or death as reported by the unblinded investigators was significantly lower in the prednisone group (10.4%) than in usual care (30.8%) (hazard ratio 0.31, 95% CI 0.11-0.86, p = 0.016). The EQ-5D visual analogue scale score as reported by the unblinded patients increased more in the prednisone group on day 7 (least squares mean difference 2.57, 95% CI 0.12-5.01 points, p = 0.040). All effects were statistically significant in the pre-specified subgroup with centrally-measured interleukin-6 >13 pg/ml. Adverse events, particularly hyperglycaemia, occurred more in the prednisone group with no difference in infection rate.
Conclusion: In this small open-label study of patients with AHF, burst steroid therapy was associated with reduced inflammation as measured by hsCRP levels at day 7 (primary endpoint). Secondary endpoints showed improved quality of life at day 7 and reduced 90-day risk of death or worsening HF. Large prospective studies are needed to evaluate these findings.
(© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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