Clinical trial NCT02392689: Improve Management of Heart Failure With Procalcitonin
Official title: Improve Management of Heart Failure With Procalcitonin - Biomarkers in Cardiology 18
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Infection
Keywords: procalcitonin
biomarker
antibiotic therapy
emergency department
cardiology
in vitro diagnostics
Lead sponsor: Brahms AG
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients who present to the emergency department (ED) with leading symptom dyspnea
2. Suspected or known heart failure
3. 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
4. Patient has given written Informed Consent within study timelines to allow antibiotic therapy within 8 hours
5. Adult patients (i.e. \>18 years of age)
6. Hospitalization for at least 1 overnight stay planned

Exclusion Criteria:

1. Patient participates in any other interventional clinical trial
2. Trauma related shortness of breath
3. Patient diagnosed with lung or thyroid cancer
4. Known terminal disease with life expectancy of less than 6 months, e.g. advanced metastasized cancer disease
5. Organ transplant requiring immunosuppression
6. Abdominal, vascular or thorax surgery within the last 30 days
7. End stage/advanced heart failure - defined by planned heart transplantation, or cardiogenic shock
8. Female patients who have given birth within 3 months before study enrolment
9. Current use of antibiotics or requirement of immediate antibiotic therapy before randomization and measurement of Procalcitonin
10. End stage renal failure requiring dialysis
11. 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
12. Patient has already participated in the clinical trial previously
13. Pregnant or lactating women
14. Patients who are institutionalized by official or judicial order
15. Dependants of the sponsor, the contract research organization (CRO), the study site or the investigator

Primary outcomes:
measure: all cause mortality
timeFrame: 90 days
Secondary outcomes:
measure: all cause mortality
timeFrame: 30 days
measure: all-cause hospital readmission
timeFrame: 30 days
measure: Number of patients with diagnosis of pneumonia during index hospitalization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Sygehus
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin - CCM
city: Berlin
country: Germany
facility: Charite Universitätmedizin Berlin - CVK
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III
city: Lubeck
country: Germany
facility: Universitäres Herzzentrum Lübeck
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: University of California-San Diego/VA San Diego Healthcare System
name: Alan Maisel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: university hospital Charitè Berlin
name: Martin Möckel, MD
role: PRINCIPAL_INVESTIGATOR
References: