Could a week of steroids help heart failure patients in the ER?
NCT ID NCT05668676
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a 7-day course of prednisone, started in the emergency department, can lower inflammation (measured by C-reactive protein) in patients with acute heart failure. Only 3 people took part, and the main goal was to see how CRP levels changed. The researchers hope that reducing inflammation might improve outcomes, but the tiny size means we cannot draw firm conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prednisone
- What this could lead to
- If it works, this could point toward a simple, short-term steroid treatment to reduce inflammation and improve recovery in acute heart failure.
- What could go wrong
- This is a very small, early-phase study with only 3 participants, so results may not apply broadly. Steroids also carry risks like infection and fluid retention.
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
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
3 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Mar 2023
- 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 Hide 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 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. Affiliation to a french social security system (beneficiary or legal) 6. Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP \> 1,500 pg/mL or BNP\>375 pg/mL and CRP \> 40 mg/L 7. Patient agrees for follow-up visit at the hospital at day 7 in case of earlier discharge and Day 30. 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 (defined by a prothrombin time \< 30%) 11. eGFR \< 30 mL/min/1.73m2 or eGFR \> 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 before 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Emergency department Hospital Pitié-Salpêtrière
Paris, 75013, France
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