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Acute Heart FailureCORTAHFNCT05916586

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

A study testing Prednisone in people with Acute Heart Failure, run by Heart Initiative at 3 sites in Armenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Heart Failure
What is being tested?
Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
3 sitesArmenia
Study dates
11 Aug 2023to 8 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 years of age
  • 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.
  • All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
  • Written informed consent to participate in the study.
  • Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
  • Patient agrees for follow-up visits at the hospital at day 7 in case of earlier discharge and Day 31.

Who cannot join

  • Anticipated life expectancy less than 6 months
  • Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
  • 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.
  • 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.
  • 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.
  • Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
Show all 21Show fewer
  • History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
  • Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
  • 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.
  • Primary liver disease considered to be life threatening
  • Renal disease or eGFR < 30 or > 80 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at inclusion or history of dialysis.
  • Systemic steroid therapy, within 30 days from inclusion.
  • Inability to consent, or patient under guardianship measure
  • Participation in another intervention trial in the past 30 days
  • Anticipated non-adherence to study protocol or follow-up.
  • Pregnant or nursing (lactating) women.
  • Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
  • Psychotic states not yet controlled by treatment
  • Concomitant administration of live vaccines and up to 3 months after end of corticotherapy administration.
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
  • Persons subject to psychiatric care without their consent

Trial locations and contacts

3 sites in 1 country.

Armenia3 sites

  • "Armenia" Republican Medical Center

    Yerevan

  • "Mikaelyan" Surgery Institute

    Yerevan

  • Erebouni Medical Center

    Yerevan

Other trials in Armenia

About this study

Official title: Effect of Short-Term Prednisone Therapy on C-reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Markers

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.

Being tested
Prednisone
Keywords
Acute Heart Failure, C-Reactive protein, Inflammation, Prednisone
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    Prednisone 40 mg orally once a day for 7 days

Study groups in NCT05916586
Study groupRoleWhat they receive
Prednisone + usual careExperimentalPrednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure
Receives: Drug: Prednisone
Usual careNo interventionUsual treatment for acute heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of CRP level

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

    Measured: 7 days

Secondary outcomes (2)

  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.

    Measured: 91 days

  2. Change in quality of life

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

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start11 Aug 2023
  3. Primary completion21 Apr 2024
  4. Study completion8 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-group, comparative, open-label, randomised, controlled trial.
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916586
Sponsor's protocol ID
CHF202301
Acronym
CORTAHF
Status last verified
Sep 2025
First submitted
14 Jun 2023
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32139695

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Prednisone in people with Acute Heart Failure, run by Heart Initiative at 3 sites in Armenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of CRP level (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916586, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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