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

NCT05668676 | Completed Phase 2 DMC

• 2 other identifiers: APHP2204282022-001604-17
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Heart Failure

Keywords

Acute heart failure; Emergency Department; Prednisone therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

  Day 7

• Comparisons on the effects on change in quality of life

  Day 30

• Symptoms of heart failure

  Day 7

• signs of heart failure

  Day 7

Study Arms (2)

Interventional group

EXPERIMENTAL

Drug: Prednisone arm

Control group

ACTIVE COMPARATOR

Other: Usual care

Interventions

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.

Control group

Prednisone arm DRUG

2 tabs of 20 mg prednisone per day during 7 days added to usual care medications

Interventional group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anticipated life expectancy less than 6 months
• Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
• Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic systemic or non- systemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
• Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
• History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
• Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
• Presence at screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract.
• Primary liver disease considered to be life threatening (defined by a prothrombin time \< 30%)
• Inability to consent, or patient under guardianship measure
• Participation in another intervention trial in the past 30 days
• Anticipated non-adherence to study protocol or follow-up.
• Pregnant or nursing (lactating) women.
• Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
• Psychotic states not yet controlled by treatment
• Concomitant administration of live vaccines and up to 3 months before end of corticotherapy administration

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yonathan FREUND, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 30, 2022
• Study Start: February 16, 2023
• Primary Completion: February 27, 2023
• Study Completion: March 20, 2023
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)