Improve Management of Heart Failure With Procalcitonin

Heart Failure Clinical Trial

— IMPACT-EU  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02392689
• Other study ID #: IMPACT-EU
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: April 14, 2018

Study information

• Verified date: July 2018
• Source: Brahms AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 759
• Est. completion date: April 14, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Infection

Intervention

Other:
• Procalcitonin
Procalcitonin guided antibiotic therapy

Locations

Country	Name	City	State
Denmark	Aalborg Sygehus	Aalborg
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Charite Universitätmedizin Berlin - CVK	Berlin
Germany	Charite Universitätsmedizin Berlin - CCM	Berlin
Germany	Klinikum Frankfurt Höchst GmbH	Frankfurt am Main
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III	Heidelberg
Germany	Universitäres Herzzentrum Lübeck	Lubeck
Germany	Klinikum Nürnberg Nord	Nürnberg
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht UMC+	Maastricht
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Brahms AG

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		90 days
Secondary	all cause mortality		30 days
Secondary	all-cause hospital readmission		30 days
Secondary	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