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

September 9, 2025 updated by: Heart Initiative

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • Erebouni Medical Center
      • Yerevan, Armenia
        • "Armenia" Republican Medical Center
      • Yerevan, Armenia
        • "Mikaelyan" Surgery Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 85 years of age
  2. 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.
  3. All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
  4. Written informed consent to participate in the study.
  5. Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
  6. Patient agrees for follow-up visits at the hospital at day 7 in case of earlier discharge and Day 31.

Exclusion Criteria:

  1. Anticipated life expectancy less than 6 months
  2. Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
  3. 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.
  4. 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.
  5. 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.
  6. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
  7. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
  8. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
  9. 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.
  10. Primary liver disease considered to be life threatening
  11. Renal disease or eGFR < 30 or > 80 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at inclusion or history of dialysis.
  12. Systemic steroid therapy, within 30 days from inclusion.
  13. Inability to consent, or patient under guardianship measure
  14. Participation in another intervention trial in the past 30 days
  15. Anticipated non-adherence to study protocol or follow-up.
  16. Pregnant or nursing (lactating) women.
  17. Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
  18. Psychotic states not yet controlled by treatment
  19. Concomitant administration of live vaccines and up to 3 months after end of corticotherapy administration.
  20. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
  21. Persons subject to psychiatric care without their consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of CRP level
Time Frame: 7 days
Change of CRP level, defined by CRP level at day 7 minus CRP level at inclusion.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHF adverse event, death, or hospital readmission
Time Frame: 91 days
Time to first event of WHF adverse event, death, or hospital readmission for decompensated HF to day 91.
91 days
Change in quality of life
Time Frame: 7 days
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Initiative

Investigators

  • Principal Investigator: Yonathan Freund, MD, Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Actual)

April 21, 2024

Study Completion (Actual)

July 8, 2024

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHF202301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Heart Failure

Clinical Trials on Prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe