Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure
Summary
This is a multicenter, parallel-group, randomized, open-label, controlled trial. Patients with a diagnosis of acute heart failure (AHF) in the emergency department (ED) or after emergency presentation to hospital will be screened and informed of the study. After signed consent, patients will be randomized into the control group (usual AHF treatment) or intervention group (usual AHF treatment + prednisone). Prednisone will be given for 7 days. Patients will be assessed at days 2, 4 or at discharge if earlier, and at day 7 at hospital visit. If the patient has been discharged before day 7, a follow-up visit will be scheduled at day 7 for endpoints assessment followed by a scheduled hospital visit at day 31 and a telephone follow-up at day 91. Study drug will be dispensed for the patient to take home until day 7.
Timeline
- Start
- 2023-08-11
- Primary completion
- 2024-04-21
- Completion
- 2024-07-08
Publications
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- Results Biegus J, Cotter G, Davison BA, Freund Y, Voors AA, Edwards C, Novosadova M, Takagi K, Hayrapetyan H, Mshetsyan A, Mayranush D, Cohen-Solal A, Ter Maaten JM, Filippatos G, Chioncel O, Sadoune M, Pagnesi M, Simon T, Metra M, Mann DL, Mebazaa A, Ponikowski P. The Effects of Burst Steroid Therapy on Short-term Decongestion in Acute Heart Failure Patients With Pro-inflammatory Activation: A Post Hoc Analysis of the CORTAHF Randomized, Open-label, Pilot Trial. J Card Fail. 2025 Feb;31(2):354-366. doi: 10.1016/j.cardfail.2024.09.002. Epub 2024 Sep 29.
- Results Pagnesi M, Cotter G, Davison BA, Freund Y, Voors AA, Edwards C, Novosadova M, Takagi K, Hayrapetyan H, Mshetsyan A, Drambyan M, Cohen-Solal A, Ter Maaten JM, Biegus J, Ponikowski P, Filippatos G, Chioncel O, Sadoune M, Simon T, Mann DL, Mebazaa A, Metra M. Burst steroid therapy and quality of life in patients with acute heart failure: Insights from the CORTAHF trial. ESC Heart Fail. 2025 Jun;12(3):1620-1629. doi: 10.1002/ehf2.15235. Epub 2025 Feb 11.
- Results Cotter G, Davison B, Freund Y, Mebazaa A, Voors A, Edwards C, Novosadova M, Takagi K, Hayrapetyan H, Mshetsyan A, Mayranush D, Cohen-Solal A, Ter Maaten JM, Biegus J, Ponikowski P, Filippatos G, Chioncel O, Pagnesi M, Simon T, Metra M, Mann DL. Corticosteroid burst therapy in patients with acute heart failure: Design of the CORTAHF pilot study. ESC Heart Fail. 2024 Oct;11(5):2672-2680. doi: 10.1002/ehf2.14930. Epub 2024 Jun 28.
- Results Cotter G, Davison BA, Freund Y, Voors AA, Edwards C, Novosadova M, Takagi K, Hayrapetyan H, Mshetsyan A, Mayranush D, Cohen-Solal A, Ter Maaten JM, Biegus J, Ponikowski P, Filippatos G, Chioncel O, Sadoune M, Pagnesi M, Simon T, Metra M, Mann DL, Mebazaa A. Burst steroid therapy for acute heart failure: The CORTAHF randomized, open-label, pilot trial. Eur J Heart Fail. 2024 Oct;26(10):2282-2292. doi: 10.1002/ejhf.3452. Epub 2024 Aug 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisone | Other / unclassified | 40 mg | Oral |