Acute heart failure (AHF) is a common discharge diagnosis in the emergency department (ED), associated with 1-month mortality of 6%, and a 30% risk rate of 1-month rehospitalisation. Current guidelines recommend the use of nitrates and low dose diuretics to treat congestion, but to date, no drug has ever shown any improved clinical outcome when given at the acute phase. Several studies suggest that there is a high inflammatory component in AHF, with elevated markers such as IL6 and C-reactive protein (CRP). As it is the case in other acute respiratory disease, a short course of steroid therapy may limit the inflammatory response and in turn, improve AHF prognosis. The objective of the study is to assess the effect of a 7-day course of steroid introduced in the ED on inflammatory response
A multicentric (5 EDs in France), phase 3, comparative, open-label, randomised controlled study in 2 parallel-group comparing usual AHF treatment (control group) with usual AHF treatment + prednisone (intervention group). The objective is to assess the effect of a 7-day course of prednisone therapy started in the ED and continued for up to 7 days on the change of CRP level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
2 tabs of 20 mg prednisone per day during 7 days added to usual care medications
Usual care alone as per European guidelines, which includes oxygen in case of hypoxia, low dose furosemide (40mg or daily dosage), and iv nitrates if no contra-indication.
Emergency department Hospital Pitié-Salpêtrière
Paris, France
Change in CRP value from inclusion to day 7
To assess the effects of prednisone therapy started in the ED and continued for up to 7 days on the change of CRP level.
Time frame: Day 7
The composite of death, or hospital readmission for decompensated HF through day 30 or worsening heart failure occurring between 24h after randomization through the earliest of discharge or day 7
Time frame: Day 30
Comparisons on the effects on change in quality of life
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7
Time frame: Day 7
Comparisons on the effects on change in quality of life
Changes in quality of life measured by the EQ-5D-5L from randomization to Day 30
Time frame: Day 30
Symptoms of heart failure
Changes in symptoms of congestion (NYHA classification, orthopnea, peripheral edema, rales, jugular venous pulse, dyspnea) at day 7
Time frame: Day 7
signs of heart failure
Changes in heart failure signs
Time frame: Day 7
Change in weight from randomization to day 7
Time frame: Day 7
Death from any cause at day 30
Time frame: Day 30
Readmission for HF or death
Time frame: 30 days
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