Viewing Study NCT05916586



Ignite Creation Date: 2024-05-06 @ 7:09 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05916586
Status: RECRUITING
Last Update Posted: 2024-01-23
First Post: 2023-06-14

Brief Title: Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure
Sponsor: Heart Initiative
Organization: Heart Initiative

Study Overview

Official Title: Effect of Short-Term Prednisone Therapy on C-reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Markers
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CORTAHF
Brief 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 11 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None