Improve Management of Heart Failure With Procalcitonin

Study Overview
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Brief Summary
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Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guided arm. Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support decision on antibiotic therapy initiation. Standard of care arm: the decision on antibiotic therapy will be based on the physicians intent to treat. The patients will be followed up 30 and 90 days after randomization to evaluate the survival status, re-hospitalizations and further antibiotic therapies.

Official Title
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Improve Management of Heart Failure With Procalcitonin - Biomarkers in Cardiology 18

Conditions
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Heart Failure, Infection

Intervention / Treatment
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* Other: Procalcitonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present to the emergency department (ED) with leading symptom dyspnea Suspected or known heart failure midregional pro atrial natriuretic peptide (MR-proANP)>300 pmol/L, brain natriuretic peptid (BNP) >350 ng/ml or N-terminal of the prohormone brain natriuretic peptide (NT-proBNP)>1800 ng/l Patient has given written Informed Consent within study timelines to allow antibiotic therapy within 8 hours Adult patients (i.e. >18 years of age) Hospitalization for at least 1 overnight stay planned Exclusion Criteria: Patient participates in any other interventional clinical trial Trauma related shortness of breath Patient diagnosed with lung or thyroid cancer Known terminal disease with life expectancy of less than 6 months, e.g. advanced metastasized cancer disease Organ transplant requiring immunosuppression Abdominal, vascular or thorax surgery within the last 30 days End stage/advanced heart failure - defined by planned heart transplantation, or cardiogenic shock Female patients who have given birth within 3 months before study enrolment Current use of antibiotics or requirement of immediate antibiotic therapy before randomization and measurement of Procalcitonin End stage renal failure requiring dialysis Patient is not willing, or it is not possible or advisable for the patient, to follow the study schedule, including antibiotic therapy and 90 days follow up Patient has already participated in the clinical trial previously Pregnant or lactating women Patients who are institutionalized by official or judicial order Dependants of the sponsor, the contract research organization (CRO), the study site or the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCT-guided<br>Blood samples are taken on day 0 and day 1 of the study. Procalcitonin (PCT) is measured and used support the decision on antibiotic therapy. PCT levels above 0.2 ng/ml: antibiotic therapy is recommended PCT levels equal/below 0.2 ng/ml: antibiotic therapy is not recommended | Other: Procalcitonin<br>* Procalcitonin guided antibiotic therapy<br>|
| No Intervention: Standard of Care<br>Blood samples are taken on day 0 and day 1 and stored for later analysis. The investigator treats the patients according to standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 30 days | 
| all-cause hospital readmission |  | 30 days | 
| Number of patients with diagnosis of pneumonia during index hospitalization |  | participants will be followed for the duration of hospital stay, an expected average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vitro diagnostics, procalcitonin, biomarker, antibiotic therapy, emergency department, cardiology