search
Back to results

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

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Prednisone arm
Usual care
Sponsored by
Assistance Publique - Hôpitaux de Paris
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, Emergency Department, Prednisone therapy

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 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. 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 (defined by a prothrombin time < 30%) eGFR < 30 mL/min/1.73m2 or eGFR > 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 before 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

  • Emergency department Hospital Pitié-SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Comparisons on the effects on change in quality of life
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7
Comparisons on the effects on change in quality of life
Changes in quality of life measured by the EQ-5D-5L from randomization to Day 30
Symptoms of heart failure
Changes in symptoms of congestion (NYHA classification, orthopnea, peripheral edema, rales, jugular venous pulse, dyspnea) at day 7
signs of heart failure
Changes in heart failure signs
Change in weight from randomization to day 7
Death from any cause at day 30
Readmission for HF or death

Full Information

First Posted
November 21, 2022
Last Updated
October 18, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05668676
Brief Title
Effect of Short-Term Prednisone Therapy on C-Reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Markers ( CORTAHF )
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 Marker
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

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

5. Study Description

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
Detailed Description
A multicentric (5 EDs in France), phase 3, comparative, open-label, randomised controlled study in 2 parallel-group comparing usual AHF treatment (control group) with usual AHF treatment + prednisone (intervention group). The objective is to assess the effect of a 7-day course of prednisone therapy started in the ED and continued for up to 7 days on the change of CRP level.

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, Emergency Department, Prednisone therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisone arm
Intervention Description
2 tabs of 20 mg prednisone per day during 7 days added to usual care medications
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CRP value from inclusion to day 7
Description
To assess the effects of prednisone therapy started in the ED and continued for up to 7 days on the change of CRP level.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
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
Time Frame
Day 30
Title
Comparisons on the effects on change in quality of life
Description
Changes in quality of life measured by the EQ-5D-5L from randomization to day 7
Time Frame
Day 7
Title
Comparisons on the effects on change in quality of life
Description
Changes in quality of life measured by the EQ-5D-5L from randomization to Day 30
Time Frame
Day 30
Title
Symptoms of heart failure
Description
Changes in symptoms of congestion (NYHA classification, orthopnea, peripheral edema, rales, jugular venous pulse, dyspnea) at day 7
Time Frame
Day 7
Title
signs of heart failure
Description
Changes in heart failure signs
Time Frame
Day 7
Title
Change in weight from randomization to day 7
Time Frame
Day 7
Title
Death from any cause at day 30
Time Frame
Day 30
Title
Readmission for HF or death
Time Frame
30 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 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. 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 (defined by a prothrombin time < 30%) eGFR < 30 mL/min/1.73m2 or eGFR > 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 before 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
Yonathan FREUND, PU-PH
Phone
0184827129
Email
yonathanfreund@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre MEBAZAA, PU-PH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonathan FREUND, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department Hospital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonathan Freund, PU-PH
Phone
01.84.82.71.29
Email
yonathanfreund@gmail.com
First Name & Middle Initial & Last Name & Degree
Frédéric ADNET, PU-PH
Phone
01.48.96.44.08
Email
frederic.adnet@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs