Short-term prednisone therapy for acute heart failure patients in the emergency department

Effect of Short-Term Prednisone Therapy on C-Reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Marker

This study tests if a week of prednisone treatment can lower inflammation and help people with acute heart failure who come to the emergency room feel better.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Paris)
• Trial ID: NCT05668676 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a 7-day course of prednisone therapy on inflammatory markers in patients with acute heart failure (AHF) who present to the emergency department. It is a multicentric, phase 3, open-label, randomized controlled study comparing standard AHF treatment with the addition of prednisone. The primary focus is to assess changes in C-reactive protein (CRP) levels, which are indicative of inflammation, following treatment. The study aims to determine if reducing inflammation can improve clinical outcomes for AHF patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who present to the emergency department with acute heart failure symptoms and elevated inflammatory markers.

Not a fit: Patients with a life expectancy of less than 6 months or those requiring mechanical ventilation prior to screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved clinical outcomes and reduced rehospitalization rates for patients with acute heart failure.

How similar studies have performed: Previous studies have suggested a potential benefit of steroid therapy in acute inflammatory conditions, but this specific approach in acute heart failure is novel.

Eligibility criteria

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

Where this trial is running

Paris

• Emergency department Hospital Pitié-Salpêtrière — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Yonathan FREUND, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Yonathan FREUND, PU-PH

Conditions: Acute Heart Failure, Acute heart failure, Emergency Department, Prednisone therapy