This is a multicenter, parallel-group, randomized, open-label, controlled trial. Patients with a diagnosis of acute heart failure (AHF) in the emergency department (ED) or after emergency presentation to hospital will be screened and informed of the study. After signed consent, patients will be randomized into the control group (usual AHF treatment) or intervention group (usual AHF treatment + prednisone). Prednisone will be given for 7 days. Patients will be assessed at days 2, 4 or at discharge if earlier, and at day 7 at hospital visit. If the patient has been discharged before day 7, a follow-up visit will be scheduled at day 7 for endpoints assessment followed by a scheduled hospital visit at day 31 and a telephone follow-up at day 91. Study drug will be dispensed for the patient to take home until day 7.
CORTAHF is a parallel-group, comparative, open-label, randomised (1:1), controlled trial. Patients with a diagnosis of AHF in the ED or after emergency presentation to hospital will be screened and informed of the study. After signed consent, patients will be randomized into the control group (usual AHF treatment) or intervention group (usual AHF treatment + prednisone). Prednisone will be given for 7 days. Patients will be assessed at days 2, 4 or at discharge if earlier, and at day 7 at hospital visit. If the patient has been discharged before day 7, a follow-up visit will be scheduled at day 7 for endpoints assessment followed by a scheduled hospital visit at day 31 and a telephone follow-up at day 91. Study drug will be dispensed for the patient to take home until day 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Prednisone 40 mg orally once a day for 7 days
"Armenia" Republican Medical Center
Yerevan, Armenia
"Mikaelyan" Surgery Institute
Yerevan, Armenia
Erebouni Medical Center
Yerevan, Armenia
Change of CRP level
Change of CRP level, defined by CRP level at day 7 minus CRP level at inclusion.
Time frame: 7 days
WHF adverse event, death, or hospital readmission
Time to first event of WHF adverse event, death, or hospital readmission for decompensated HF to day 91.
Time frame: 91 days
Change in quality of life
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7.
Time frame: 7 days
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