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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 18 to 85 years of age

• Unplanned ED visit within the 12 hours prior to Screening with acute or worsening dyspnea and/or orthopnea, and Pulmonary congestion on chest X-ray or lung ultrasound.

• All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.

• Written informed consent to participate in the study.

• Affiliation to a french social security system (beneficiary or legal)

• Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP \> 1,500 pg/mL or BNP\>375 pg/mL and CRP \> 40 mg/L

• Patient agrees for follow-up visit at the hospital at day 7 in case of earlier discharge and Day 30.

Locations
Other Locations
France
Emergency department Hospital Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Yonathan FREUND, PU-PH
yonathanfreund@gmail.com
0184827129
Backup
Alexandre MEBAZAA, PU-PH
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2024-03
Participants
Target number of participants: 120
Treatments
Experimental: Interventional group
Active_comparator: Control group
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov