Improve Management of heart failure with Procalcitonin - Biomarkers in Cardiology 18 (Short title: IMPACT-EU)
- Conditions
- bacterial infectionheart failure10019280
- Registration Number
- NL-OMON42767
- Lead Sponsor
- Thermo Fisher Scientific BRAHMS GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Patients who present to the ED with leading symptom dyspnea
2. Suspected or known heart failure
3. MR-proANP>300 pmol/L, BNP>350 ng/ml or NT-proBNP>1800 ng/l
4. Patient has given written Informed Consent within study timelines to allow antibiotic treatment within 8 hours
5. Adult patients (i.e. >18 years of age)
6. Hospitalization for at least 1 overnight stay planned
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 HF * 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 PCT
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 CRO, the study site or the investigator
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>90-day all-cause mortality of patients (# of days from randomization)</p><br>
- Secondary Outcome Measures
Name Time Method <p>a) 30-day all-cause mortality<br /><br>b) Hospital all-cause readmission within 30 days<br /><br>c) Number of patients with diagnosis of pneumonia during index hospitalization</p><br>