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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001604-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone arm | Drug | 2 tabs of 20 mg prednisone per day during 7 days added to usual care medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 30 | |
| Comparisons on the effects on change in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yonathan FREUND, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency department Hospital Pitié-Salpêtrière | Paris | 75013 | France |
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| Usual care | Other | 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. |
|
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7
| 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 | Day 30 |
| Symptoms of heart failure | Changes in symptoms of congestion (NYHA classification, orthopnea, peripheral edema, rales, jugular venous pulse, dyspnea) at day 7 | Day 7 |
| signs of heart failure | Changes in heart failure signs | Day 7 |
| Change in weight from randomization to day 7 | Day 7 |
| Death from any cause at day 30 | Day 30 |
| Readmission for HF or death | 30 days |
| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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