NCT05916586

Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Heart Initiative · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone 40 mg orally once a day for 7 days

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-04-21
• Completion: 2024-07-08
• First posted: 2023-06-23
• Last updated: 2025-09-15

Locations

3 sites across 1 country: Armenia