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CompletedNCT05916586CORTAHFUpdated Sep 15, 2025

Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure

An interventional study of Prednisone in Acute Heart Failure, sponsored by Heart Initiative. Completed at 3 sites in Armenia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Heart Initiative · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Acute Heart Failure

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Keywords

  • Acute Heart Failure
  • C-Reactive protein
  • Inflammation
  • Prednisone
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18 to 85 years of age
  2. Unplanned ED visit or hospital presentation within the 12 hours prior to Screening with acute or worsening dyspnea and/or orthopnea, and pulmonary congestion on chest X-ray or lung ultrasound.
  3. All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
  4. Written informed consent to participate in the study.
  5. Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
  6. Patient agrees for follow-up visits at the hospital at day 7 in case of earlier discharge and Day 31.

Exclusion criteria

Exclusion Criteria:

  1. Anticipated life expectancy less than 6 months
  2. Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
  3. Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
  4. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to inclusion.
  5. Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia \<45 beats per minute), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.
  6. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
  7. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
  8. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
  9. Presence at screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract.
  10. Primary liver disease considered to be life threatening
  11. Renal disease or eGFR \< 30 or > 80 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at inclusion or history of dialysis.
  12. Systemic steroid therapy, within 30 days from inclusion.
  13. Inability to consent, or patient under guardianship measure
  14. Participation in another intervention trial in the past 30 days
  15. Anticipated non-adherence to study protocol or follow-up.
  16. Pregnant or nursing (lactating) women.
  17. Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
  18. Psychotic states not yet controlled by treatment
  19. Concomitant administration of live vaccines and up to 3 months after end of corticotherapy administration.
  20. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
  21. Persons subject to psychiatric care without their consent
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Prednisone + usual care

    Prednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure

    Drug: Prednisone

  • No intervention
    Usual care

    Usual treatment for acute heart failure

Interventions

  • DrugPrednisone

    Prednisone 40 mg orally once a day for 7 days

05

What researchers measure

Primary outcomes

  1. Change of CRP level

    Change of CRP level, defined by CRP level at day 7 minus CRP level at inclusion.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 91 days

  2. Change in quality of life

    Changes in quality of life measured by the EQ-5D-5L from randomization to day 7.

    Time frame: 7 days

06

Study locations

3 sites
  • "Armenia" Republican Medical Center
    Yerevan, Armenia
  • "Mikaelyan" Surgery Institute
    Yerevan, Armenia
  • Erebouni Medical Center
    Yerevan, Armenia
07

References and documents

Publications

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  • 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. PubMed 12414454 ↗
  • 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. PubMed 26719808 ↗
  • Cotter G, Dittrich HC, Weatherley BD, Bloomfield DM, O'Connor CM, Metra M, Massie BM; Protect Steering Committee, Investigators, and Coordinators. The PROTECT pilot study: a randomized, placebo-controlled, dose-finding study of the adenosine A1 receptor antagonist rolofylline in patients with acute heart failure and renal impairment. J Card Fail. 2008 Oct;14(8):631-40. doi: 10.1016/j.cardfail.2008.08.010. Epub 2008 Sep 14. PubMed 18926433 ↗
  • Davison BA, Senger S, Sama IE, Koch GG, Mebazaa A, Dickstein K, Samani NJ, Metra M, Anker SD, Cleland JG, Ng LL, Mordi IR, Zannad F, Filippatos GS, Hillege HL, Ponikowski P, van Veldhuisen DJ, Lang CC, van der Meer P, Nunez J, Bayes-Genis A, Edwards C, Voors AA, Cotter G. Is acute heart failure a distinctive disorder? An analysis from BIOSTAT-CHF. Eur J Heart Fail. 2021 Jan;23(1):43-57. doi: 10.1002/ejhf.2077. Epub 2021 Jan 22. PubMed 33340221 ↗
  • Du Clos TW. Function of C-reactive protein. Ann Med. 2000 May;32(4):274-8. doi: 10.3109/07853890009011772. PubMed 10852144 ↗
  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. PubMed 10109801 ↗
  • Freund Y, Cachanado M, Delannoy Q, Laribi S, Yordanov Y, Gorlicki J, Chouihed T, Feral-Pierssens AL, Truchot J, Desmettre T, Occelli C, Bobbia X, Khellaf M, Ganansia O, Bokobza J, Balen F, Beaune S, Bloom B, Simon T, Mebazaa A. Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial. JAMA. 2020 Nov 17;324(19):1948-1956. doi: 10.1001/jama.2020.19378. PubMed 33201202 ↗
  • Goonewardena SN, Stein AB, Tsuchida RE, Rattan R, Shah D, Hummel SL. Monocyte Subsets and Inflammatory Cytokines in Acute Decompensated Heart Failure. J Card Fail. 2016 May;22(5):358-65. doi: 10.1016/j.cardfail.2015.12.014. Epub 2015 Dec 17. PubMed 26705751 ↗
  • Kalogeropoulos AP, Tang WH, Hsu A, Felker GM, Hernandez AF, Troughton RW, Voors AA, Anker SD, Metra M, McMurray JJ, Massie BM, Ezekowitz JA, Califf RM, O'Connor CM, Starling RC, Butler J. High-sensitivity C-reactive protein in acute heart failure: insights from the ASCEND-HF trial. J Card Fail. 2014 May;20(5):319-26. doi: 10.1016/j.cardfail.2014.02.002. Epub 2014 Feb 12. PubMed 24530944 ↗
  • Le Conte P, Terzi N, Mortamet G, Abroug F, Carteaux G, Charasse C, Chauvin A, Combes X, Dauger S, Demoule A, Desmettre T, Ehrmann S, Gaillard-Le Roux B, Hamel V, Jung B, Kepka S, L'Her E, Martinez M, Milesi C, Morawiec E, Oberlin M, Plaisance P, Pouyau R, Raherison C, Ray P, Schmidt M, Thille AW, Truchot J, Valdenaire G, Vaux J, Viglino D, Voiriot G, Vrignaud B, Jean S, Mariotte E, Claret PG. Management of severe asthma exacerbation: guidelines from the Societe Francaise de Medecine d'Urgence, the Societe de Reanimation de Langue Francaise and the French Group for Pediatric Intensive Care and Emergencies. Ann Intensive Care. 2019 Oct 10;9(1):115. doi: 10.1186/s13613-019-0584-x. PubMed 31602529 ↗
  • Liu C, Liu G, Zhou C, Ji Z, Zhen Y, Liu K. Potent diuretic effects of prednisone in heart failure patients with refractory diuretic resistance. Can J Cardiol. 2007 Sep;23(11):865-8. doi: 10.1016/s0828-282x(07)70840-1. PubMed 17876376 ↗
  • Liu C, Ge N, Zhai JL, Zhang JX. Dexamethasone-induced diuresis is associated with inhibition of the renin-angiotensin-aldosterone system in rats. Kaohsiung J Med Sci. 2016 Dec;32(12):614-619. doi: 10.1016/j.kjms.2016.09.007. Epub 2016 Oct 27. PubMed 27914612 ↗
  • Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282. PubMed 25992918 ↗
  • Mebazaa A, Yilmaz MB, Levy P, Ponikowski P, Peacock WF, Laribi S, Ristic AD, Lambrinou E, Masip J, Riley JP, McDonagh T, Mueller C, deFilippi C, Harjola VP, Thiele H, Piepoli MF, Metra M, Maggioni A, McMurray J, Dickstein K, Damman K, Seferovic PM, Ruschitzka F, Leite-Moreira AF, Bellou A, Anker SD, Filippatos G. Recommendations on pre-hospital & early hospital management of acute heart failure: a consensus paper from the Heart Failure Association of the European Society of Cardiology, the European Society of Emergency Medicine and the Society of Academic Emergency Medicine. Eur J Heart Fail. 2015 Jun;17(6):544-58. doi: 10.1002/ejhf.289. Epub 2015 May 21. PubMed 25999021 ↗
  • Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendano P, Bacal F, Bohm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverria LE, Ferrari R, Goland S, Goncalvesova E, Goudev A, Kober L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Spinar J, Squire I, Stepinska J, Van Mieghem W, von Lewinski D, Wikstrom G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsody P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291. PubMed 31433919 ↗
  • Nieminen MS, Dickstein K, Fonseca C, Serrano JM, Parissis J, Fedele F, Wikstrom G, Agostoni P, Atar S, Baholli L, Brito D, Colet JC, Edes I, Gomez Mesa JE, Gorjup V, Garza EH, Gonzalez Juanatey JR, Karanovic N, Karavidas A, Katsytadze I, Kivikko M, Matskeplishvili S, Merkely B, Morandi F, Novoa A, Oliva F, Ostadal P, Pereira-Barretto A, Pollesello P, Rudiger A, Schwinger RH, Wieser M, Yavelov I, Zymlinski R. The patient perspective: Quality of life in advanced heart failure with frequent hospitalisations. Int J Cardiol. 2015 Jul 15;191:256-64. doi: 10.1016/j.ijcard.2015.04.235. Epub 2015 May 1. PubMed 25981363 ↗
  • Oppe, M., R. Rabin, et al. (2008). EQ-5D User Guide. Version 1.0. Rotterdam, The Netherlands, The EuroQol Group.
  • 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. PubMed 34031890 ↗
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  • Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3):1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar. PubMed 28298398 ↗
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  • 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. PubMed 39353506 ↗
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  • 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. PubMed 38943232 ↗
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Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05916586
Lead sponsor
Heart Initiative
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
Aug 11, 2023
Primary completion
Apr 21, 2024
Completion
Jul 8, 2024
Last update
Sep 15, 2025

Study contacts

Yonathan Freund, MD
principal investigator · Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, Paris, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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