Impact of Prednisone on Inflammation in Acute Heart Failure Patients

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

This study is testing if adding prednisone to standard treatment can help reduce inflammation in people with acute heart failure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Heart Initiative (Academic / other)
• Drugs / interventions: prednisone
• Locations: 3 sites (Yerevan and 2 other locations)
• Trial ID: NCT05916586 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of short-term prednisone therapy on C-reactive protein levels in patients diagnosed with acute heart failure. It is a multicenter, randomized, open-label trial where participants will be assigned to either a control group receiving standard treatment or an intervention group receiving standard treatment plus prednisone for seven days. Patients will be monitored at various intervals, including hospital visits and follow-up assessments, to evaluate the impact of the treatment on inflammation and heart failure symptoms. The study aims to provide insights into the role of prednisone in managing acute heart failure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who present with acute heart failure symptoms and meet specific biomarker criteria.

Not a fit: Patients with a life expectancy of less than six months or those requiring mechanical ventilation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for acute heart failure by reducing inflammation and enhancing patient outcomes.

How similar studies have performed: While the use of corticosteroids in heart failure is a topic of ongoing research, this specific approach with prednisone in acute heart failure is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Yerevan and 2 other locations

• "Armenia" Republican Medical Center — Yerevan, Armenia (Recruiting)
• "Mikaelyan" Surgery Institute — Yerevan, Armenia (Recruiting)
• Erebouni Medical Center — Yerevan, Armenia (Recruiting)

Study contacts

• Principal investigator: Yonathan Freund, MD — Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, Paris, France
• Study coordinator: Maria Novosadova, MD

Conditions Acute Heart Failure; C-Reactive protein; Inflammation; Prednisone