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Improve Management of Heart Failure With Procalcitonin (IMPACT-EU)

Primary Purpose

Heart Failure, Infection

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Procalcitonin

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring procalcitonin, biomarker, antibiotic therapy, emergency department, cardiology, in vitro diagnostics

Eligibility Criteria

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

Sites / Locations

Aalborg Sygehus
Herlev Hospital
Odense University Hospital
Kerckhoff-Klinik
Charite Universitätsmedizin Berlin - CCM
Charite Universitätmedizin Berlin - CVK
Universitätsklinikum Frankfurt
Klinikum Frankfurt Höchst GmbH
Universitätsmedizin Göttingen
Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III
Universitäres Herzzentrum Lübeck
Klinikum Nürnberg Nord
University Medical Center Groningen
Maastricht UMC+
Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PCT-guided

Standard of Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

all cause mortality

all-cause hospital readmission

Number of patients with diagnosis of pneumonia during index hospitalization

Full Information

NCT ID

NCT02392689

First Posted

March 9, 2015

Last Updated

July 20, 2018

Sponsor

Brahms AG

1. Study Identification

Unique Protocol Identification Number

NCT02392689

Brief Title

Improve Management of Heart Failure With Procalcitonin

Acronym

IMPACT-EU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

At 75% patient completion overall mortality was much lower than expected and without significant difference at day 90. No chance to reach the primary endpoint.

Study Start Date

March 2015 (Actual)

Primary Completion Date

April 5, 2018 (Actual)

Study Completion Date

April 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brahms AG

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Infection

Keywords

procalcitonin, biomarker, antibiotic therapy, emergency department, cardiology, in vitro diagnostics

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

759 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCT-guided

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Procalcitonin

Intervention Description

Procalcitonin guided antibiotic therapy

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

90 days

Secondary Outcome Measure Information:

Title

all cause mortality

Time Frame

30 days

Title

all-cause hospital readmission

Time Frame

30 days

Title

Number of patients with diagnosis of pneumonia during index hospitalization

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Maisel, MD

Organizational Affiliation

University of California-San Diego/VA San Diego Healthcare System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Möckel, MD

Organizational Affiliation

university hospital Charitè Berlin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aalborg Sygehus

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Kerckhoff-Klinik

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Charite Universitätsmedizin Berlin - CCM

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Charite Universitätmedizin Berlin - CVK

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Universitätsklinikum Frankfurt

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Klinikum Frankfurt Höchst GmbH

City

Frankfurt am Main

ZIP/Postal Code

65929

Country

Germany

Facility Name

Universitätsmedizin Göttingen

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitäres Herzzentrum Lübeck

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Klinikum Nürnberg Nord

City

Nürnberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9713

Country

Netherlands

Facility Name

Maastricht UMC+

City

Maastricht

ZIP/Postal Code

6229

Country

Netherlands

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

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Improve Management of Heart Failure With Procalcitonin

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