Heart FailureIMPACT-EUNCT02392689
Improve Management of Heart Failure With Procalcitonin
A study testing Procalcitonin in people with Heart Failure and Infection, run by Brahms AG at 15 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Infection
- What is being tested?
- Procalcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Mar 2015to 14 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany9 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Charite Universitätsmedizin Berlin - CCM
Berlin, 10117
Charite Universitätmedizin Berlin - CVK
Berlin, 13353
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, 65929
Universitätsmedizin Göttingen
Göttingen, 37075
Medizinische Universitätsklinik Heidelberg - Medizinische Klinik III
Heidelberg, 69120
Universitäres Herzzentrum Lübeck
Lübeck, 23538
Klinikum Nürnberg Nord
Nuremberg, 90419
Denmark3 sites
Aalborg Sygehus
Aalborg, 9000
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Netherlands2 sites
University Medical Center Groningen
Groningen, 9713
Maastricht UMC+
Maastricht, 6229
About this study
Official title: Improve Management of Heart Failure With Procalcitonin - Biomarkers in Cardiology 18
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.
- Conditions
- Heart Failure, Infection
- Being tested
- Procalcitonin
- Keywords
- procalcitonin, biomarker, antibiotic therapy, emergency department, cardiology, in vitro diagnostics
- Medical subject headings
- Heart Failure, Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninOther
Procalcitonin guided antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| PCT-guided | Experimental | 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 Receives: Other: Procalcitonin |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 90 days
Secondary outcomes (3)
all cause mortality
Measured: 30 days
all-cause hospital readmission
Measured: 30 days
Number of patients with diagnosis of pneumonia during index hospitalization
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion5 Apr 2018
- Study completion14 Apr 2018
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brahms AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Maisel, MD, Principal investigator, University of California-San Diego/VA San Diego Healthcare SystemMartin Möckel, MD, Principal investigator, university hospital Charitè Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392689
- Sponsor's protocol ID
- IMPACT-EU
- Acronym
- IMPACT-EU
- Status last verified
- Jul 2018
- First submitted
- 9 Mar 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Management of Heart Failure With Procalcitonin - Biomarkers in Cardiology 18
- ClinicalTrials.gov ID
- NCT02392689
- Acronym / sponsor ID
- IMPACT-EU / IMPACT-EU
- Conditions
- Heart Failure, Infection
- Keywords
- procalcitonin, biomarker, antibiotic therapy, emergency department, cardiology, in vitro diagnostics
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Brahms AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 14 Apr 2018 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT-guided | Experimental | Other: ProcalcitoninBlood 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 |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcalcitoninProcalcitonin guided antibiotic therapy | Other | PCT-guided |
Primary outcome
all cause mortality
Time frame: 90 days
3 secondary outcomes
all cause mortality
Time frame: 30 days
all-cause hospital readmission
Time frame: 30 days
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Maisel, MD principal investigator
University of California-San Diego/VA San Diego Healthcare System
Martin Möckel, MD principal investigator
university hospital Charitè Berlin
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin in people with Heart Failure and Infection, run by Brahms AG at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Denmark, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.