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

Sponsor

Heart Initiative (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05916586

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 30 and a telephone follow-up at day 90. Study drug will be dispensed for the patient to take home until day 7.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure	Drug: Prednisone	N/A

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 30 and a telephone follow-up at day 90. Study drug will be dispensed for the patient to take home until day 7.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel-group, comparative, open-label, randomised, controlled trial.Parallel-group, comparative, open-label, randomised, controlled trial.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisone + usual care Prednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure	Drug: Prednisone Prednisone 40 mg orally once a day for 7 days
No Intervention: Usual care Usual treatment for acute heart failure

Arm

Intervention/Treatment

Experimental: Prednisone + usual care

Prednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure

Drug: Prednisone

Prednisone 40 mg orally once a day for 7 days

No Intervention: Usual care

Usual treatment for acute heart failure

Outcome Measures

Primary Outcome Measures

Change of CRP level [7 days]
Change of C-reactive protein (CRP) level, defined by CRP level at day 7 minus CRP level at inclusion

Secondary Outcome Measures

WHF, death, or hospital readmission [30 days]
The composite of worsening heart failure (WHF), death, or hospital readmission for decompensated HF at day 30. WHF is defined as worsening signs and/or symptoms of HF that require an intensification of intravenous therapy (including initiation or re-initiation or dose increase) for HF or mechanical ventilatory, renal or circulatory support (occurring between 24 hours after randomization and the earlier of discharge or day 7).
Change in quality of life [7 days]
Changes in quality of life measured by the EQ-5D-5L visual analog scale (VAS) from randomization to day 7 (approximately 144 hours after randomization).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 85 years of age
Unplanned ED visit or hospital presentation 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.
Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
Patient agrees for follow-up visits at the hospital at day 7 in case of earlier discharge and Day 30.

Exclusion Criteria:

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.
Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to inclusion.
Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.
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
Renal disease or eGFR < 30 or > 80 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at inclusion or history of dialysis.
Systemic steroid therapy, within 30 days from inclusion.
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 after end of corticotherapy administration.
Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
Persons subject to psychiatric care without their consent