IMPACT-EU: Improve Management of Heart Failure With Procalcitonin

Sponsor

Brahms AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT02392689

Collaborator

(none)

759

Enrollment

Locations

Arms

37.5

Actual Duration (Months)

50.6

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Infection	Other: Procalcitonin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

759 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Apr 5, 2018

Actual Study Completion Date :

Apr 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCT-guided 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 Procalcitonin guided antibiotic therapy
No Intervention: Standard of Care 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.

Arm

Intervention/Treatment

Experimental: PCT-guided

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

Procalcitonin guided antibiotic therapy

No Intervention: Standard of Care

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.

Outcome Measures

Primary Outcome Measures

all cause mortality [90 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aalborg Sygehus	Aalborg	Denmark	9000
2	Herlev Hospital	Herlev	Denmark	2730
3	Odense University Hospital	Odense	Denmark	5000
4	Kerckhoff-Klinik	Bad Nauheim	Germany	61231
5	Charite Universitätsmedizin Berlin - CCM	Berlin	Germany	10117
6	Charite Universitätmedizin Berlin - CVK	Berlin	Germany	13353
7	Universitätsklinikum Frankfurt	Frankfurt am Main	Germany	60596
8	Klinikum Frankfurt Höchst GmbH	Frankfurt am Main	Germany	65929
9	Universitätsmedizin Göttingen	Göttingen	Germany	37075
10	Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III	Heidelberg	Germany	69120
11	Universitäres Herzzentrum Lübeck	Lubeck	Germany	23538
12	Klinikum Nürnberg Nord	Nürnberg	Germany	90419
13	University Medical Center Groningen	Groningen	Netherlands	9713
14	Maastricht UMC+	Maastricht	Netherlands	6229
15	Hospital Clinico San Carlos	Madrid	Spain	28040

Sponsors and Collaborators

Brahms AG

Investigators

Principal Investigator: Alan Maisel, MD, University of California-San Diego/VA San Diego Healthcare System
Principal Investigator: Martin Möckel, MD, university hospital Charitè Berlin