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Steroid short course may cool inflammation in heart failure

NCT ID NCT05916586

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a 7-day course of prednisone, a steroid, can lower inflammation in people with acute heart failure. 101 emergency department patients were randomly assigned to get either standard care or standard care plus prednisone. The main goal was to see if CRP, a marker of inflammation, dropped more in the prednisone group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisone (a steroid anti-inflammatory drug)
What this could lead to
If it works, this could point toward a way to reduce inflammation and improve recovery in acute heart failure patients.
What could go wrong
This is a small, completed trial with 101 participants, so results may not apply to everyone. Prednisone can have side effects like high blood sugar or infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

101 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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

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Conditions

The condition(s) this trial relates to.

heart failure Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • "Armenia" Republican Medical Center

    Yerevan, Armenia

  • "Mikaelyan" Surgery Institute

    Yerevan, Armenia

  • Erebouni Medical Center

    Yerevan, Armenia

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