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

Primary Purpose

Acute Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
Heart Initiative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Acute Heart Failure, C-Reactive protein, Inflammation, Prednisone

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Prednisone + usual care

    Usual care

    Arm Description

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

    Usual treatment for acute heart failure

    Outcomes

    Primary Outcome Measures

    Change of CRP level
    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
    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
    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).

    Full Information

    First Posted
    June 14, 2023
    Last Updated
    June 14, 2023
    Sponsor
    Heart Initiative
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05916586
    Brief Title
    Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure
    Acronym
    CORTAHF
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Heart Initiative

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Heart Failure
    Keywords
    Acute Heart Failure, C-Reactive protein, Inflammation, Prednisone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel-group, comparative, open-label, randomised, controlled trial.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prednisone + usual care
    Arm Type
    Experimental
    Arm Description
    Prednisone tablets, 40 mg once a day orally, for 7 days plus usual treatment for acute heart failure
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Usual treatment for acute heart failure
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Intervention Description
    Prednisone 40 mg orally once a day for 7 days
    Primary Outcome Measure Information:
    Title
    Change of CRP level
    Description
    Change of C-reactive protein (CRP) level, defined by CRP level at day 7 minus CRP level at inclusion
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    WHF, death, or hospital readmission
    Description
    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).
    Time Frame
    30 days
    Title
    Change in quality of life
    Description
    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).
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Novosadova, MD
    Phone
    +41614851250
    Email
    MariaNovosadova@momentum-research.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gad Cotter, MD
    Email
    gadcotter@momentum-research.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yonathan Freund, MD
    Organizational Affiliation
    Emergency Department, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, Paris, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure

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