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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.
CORTAHF is a parallel-group, comparative, open-label, randomised (1:1), controlled trial. Patients with a diagnosis of AHF in the 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone + usual care | Experimental | Prednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure |
|
| Usual care | No Intervention | Usual treatment for acute heart failure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone 40 mg orally once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of CRP level | Change of CRP level, defined by CRP level at day 7 minus CRP level at inclusion. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| WHF adverse event, death, or hospital readmission | Time to first event of WHF adverse event, death, or hospital readmission for decompensated HF to day 91. | 91 days |
| Change in quality of life | Changes in quality of life measured by the EQ-5D-5L from randomization to day 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yonathan Freund, MD | Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Armenia" Republican Medical Center | Yerevan | Armenia | ||||
| "Mikaelyan" Surgery Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32139695 | Background | Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7. | |
| 12414454 | Background | Burstin H. "Crossing the Quality Chasm" in emergency medicine. Acad Emerg Med. 2002 Nov;9(11):1074-7. doi: 10.1111/j.1553-2712.2002.tb01560.x. No abstract available. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Parallel-group, comparative, open-label, randomised, controlled trial.
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| 7 days |
| Yerevan |
| Armenia |
| Erebouni Medical Center | Yerevan | Armenia |
| 26719808 | Background | Cannon JA, McKean AR, Jhund PS, McMurray JJ. What can we learn from RELAX-AHF compared to previous AHF trials and what does the future hold? Open Heart. 2015 Dec 23;2(1):e000283. doi: 10.1136/openhrt-2015-000283. eCollection 2015. |
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| 34031890 | Background | Raess N, Schuetz P, Cesana-Nigro N, Winzeler B, Urwyler SA, Schaedelin S, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M, Blum CA. Influence of Prednisone on Inflammatory Biomarkers in Community-Acquired Pneumonia: Secondary Analysis of a Randomized Trial. J Clin Pharmacol. 2021 Nov;61(11):1406-1414. doi: 10.1002/jcph.1914. Epub 2021 Jul 27. |
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| 39353506 | Result | 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. |
| 39934967 | Result | 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. |
| 38943232 | Result | 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. |
| 39211989 | Result | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |