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Active, not recruitingNCT05699564ACE4Updated Apr 28, 2026

Akershus Cardiac Examination 4 Study

An interventional study of Early biomarker-based cardiological assessment in Heart Failure and Tachypnea, sponsored by University Hospital, Akershus. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
574
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients hospitalized with tachypnea, defined as respiratory rate ≥20/ min, have substantial mortality and may suffer from different conditions, including acute heart failure (HF). Symptoms of HF can be difficult to identify and \~15% of patients with HF will not be correctly diagnosed by the treating physician in the Emergency Department. Biomarkers like B-type natriuretic peptides and cardiac troponins improve diagnostic accuracy and risk stratification. Whether early, structured biomarker assessment and structured feedback in the patient's electronic health records improve management and outcomes among unselected patients with tachypnea have previously not been explored in a randomized controlled trial.

The main research question of the study is to determine whether early structured biomarker assessment in unselected patients with tachypnea extends the time to the first event for either (1) all-cause readmission or (2) all-cause mortality; i.e. time to the combined endpoint, compared to the current strategy/standard care

02

Conditions studied

  • Heart Failure
  • Tachypnea

Keywords

  • biomarker
  • tachypnea
  • heart failure
  • echocardiography
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 574 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients ≥18 years old
  • Tachypnea (respiratory rate ≥20/min)
  • Admission to Departments under the Division of Medicine at Akershus University Hospital, except the Department of Neurology
  • \<24 h from hospital admittance to inclusion in the study
  • Signed written during the initial phase of the hospitalization

Exclusion criteria

Exclusion Criteria:

  • Previously included into the study (in case of patients presenting with a second hospitalization during the study period)
  • Known or suspected cancer outside of local control, documented in medical records, at the time of patient inclusion or diagnosed in relation to the index hospitalization
  • Neurological condition with short ; e.g. ALS, documented in medical records during screening prior to study entry
  • Other non-cardiac disease with life expectancy below 1 year, documented in medical records during screening prior to study entry
  • Obvious non-cardiac cause for tachypnea based on medical records and clinical findings during screening prior to study entry; e.g. anaphylaxis in young patient with known allergy, dyspnea after direct chest trauma, or young patient with fever and positive Covid-19 test on admission.
  • Patient assessed as non-Internal Medicine patient; e.g. surgical patient
  • Patients unwilling or unable to comply with the protocol, including Glasgow Coma Scale \<13 on the time of study inclusion
  • Patients that are intubated for invasive ventilatory therapy before or shortly after hospital admission
  • History of non-compliance to medical management and patients who are considered potentially unreliable, based on documentation in medical records, during screening prior to study entry
  • History or evidence of alcohol or drug abuse with the last 12 months, based on medical records and clinical findings during screening prior to study entry, that will influence study participation
  • Any surgical or medical condition, based on medical records and clinical findings during screening prior to study entry, that will impair the ability of the patient to participate in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
574 participants (actual)

Study arms

  • Experimental
    Early biomarker-based cardiological assessment and structured feedback in the EHR

    We will perform cardiac biomarker testing with NT-proBNP and hs-cTnT measurements on emergency department admission in all participants, regardless of randomization status. The results will be provided in the patient's EHR, regardless of randomization status. For patients randomized to the intervention group, we will provide a note in the patient's EHR that includes assessment of probability that myocardial injury or dysfunction are the underlying pathophysiology responsible for tachypnea, as evaluated by the cardiac biomarker algorithm of the study. We will inform on general recommendations for work up and treatment.

    Other: Early biomarker-based cardiological assessment

  • No intervention
    Standard of care

    Routine standard of care according to the treating physician

Interventions

  • OtherEarly biomarker-based cardiological assessment

    We will perform cardiac biomarker testing with NT-proBNP and hs-cTnT measurements on emergency department admission in all participants, regardless of randomization status. The results will be provided in the patient's EHR, regardless of randomization status. For patients randomized to the intervention group, we will provide a note in the patient's EHR that includes assessment of probability that myocardial injury or dysfunction are the underlying pathophysiology responsible for tachypnea, as evaluated by the cardiac biomarker algorithm of the study. We will inform on general recommendations for work up and treatment.

06

What researchers measure

Primary outcomes

  1. Composite of all-cause hospital readmission or all-cause mortality

    Composite of all-cause hospital readmission or all-cause mortality after discharge from index hospitalization

    Time frame: 12 months after discharge from index hospitalization

Secondary outcomes

  1. Hospital length of stay

    Hospital length of stay during the index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  2. Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit

    Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit during the index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  3. 30-day all-cause readmission

    30-day all-cause readmission after discharge from index hospitalization

    Time frame: 30-days after discharge from index hospitalization

  4. Time to all-cause readmission

    Time to first all-cause readmission after discharge from index hospitalization

    Time frame: 12 months after discharge from index hospitalization

  5. Number of all-cause readmission

    Number of all-cause readmissions after discharge from index hospitalization

    Time frame: 12 months after discharge from index hospitalization

  6. All-cause mortality

    Time to all-cause mortality after discharge from index hospitalization

    Time frame: 12 months after discharge from index hospitalization

  7. Total cost of hospitalization

    Total cost of hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  8. All-cause mortality

    All-cause mortality during the index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  9. Difference in cardiac biomarker concentrations during index hospitalization

    Difference in the cardiac troponin T and/or I and B-type natriuretic peptide and/or N-terminal pro-B-type natriuretic peptide concentrations from hospital admission to discharge

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  10. Difference in guideline-defined medical therapy for heart failure

    Difference in guideline-defined medical therapy for heart failure, as defined by international guidelines, at discharge after index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  11. Cost-utility

    Cost-utility for the intervention strategy

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

Other outcomes

  1. Assessing primary and secondary outcomes with patients stratified by concentrations of NT-proBNP measured at admission

    We will assess all the primary and secondary outcomes of the study in patients stratified according to concentrations of NT-proBNP (\< 300 ng/L, 300-449ng/L, 450-899ng/L, 900-1799ng/L, \>1799ng/L) measured at admission of the index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  2. Assessing primary and secondary outcomes with patients stratified by concentrations of cardiac troponin T measured at admission

    We will assess all the primary and secondary outcomes of the study in patients stratified according to concentrations of cardiac troponin T (\<10ng/L, 10-89ng/L), \>89ng/L) measured at admission of the index hospitalization

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  3. Assessing accuracy for HF2FPEF score assessed during index hospitalization for diagnosing heart failure with preserved ejection fraction

    Using c-statistics, we will assess the diagnostic accuracy of the H2FPEF score assessed during index hospitalization to predict heart failure with preserved ejection fraction in the total cohort of study patients

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  4. Assessing accuracy for HFA-PEFF score for diagnosing heart failure with preserved ejection fraction

    Using c-statistics, we will assess the diagnostic accuracy of the HFA-PEFF score assessed during index hospitalization to predict heart failure with preserved ejection fraction in the total cohort of study patients

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  5. Assessing accuracy for NT-proBNP measured at hospital admission for diagnosing heart failure with preserved ejection fraction

    Using c-statistics, we will assess the diagnostic accuracy of continuous concentrations of NT-proBNP measured at hospital admission to predict heart failure with preserved ejection fraction in the total cohort of study patients

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  6. Assessing accuracy for cardiac troponin T measured at hospital admission for diagnosing heart failure with preserved ejection fraction

    Using c-statistics, we will assess the diagnostic accuracy of continuous concentrations of cardiac troponin T measured at hospital admission to predict heart failure with preserved ejection fraction in the total cohort of study patients

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  7. Assessing primary and secondary outcomes in the subgroup of patients classified as hospitalized due to heart failure

    We will assess all the primary and secondary outcomes of the study in the subgroup of patients with heart failure as the adjudicated cause of tachypnea.

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

  8. Assessing primary and secondary outcomes in the subgroups of patients with heart failure with reduced ejection fraction, heart failure with mildly reduced ejection, and heart failure with preserved ejection fraction

    We will assess all the primary and secondary outcomes of the study in the subgroups of patients with heart failure with reduced ejection fraction, heart failure with mildly reduced ejection, and heart failure with preserved ejection fraction as the adjudicated cause of tachypnea.

    Time frame: From admission to discharge of index hospitalization, assessed up to 12 months

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Mar 2025, 24 months.

Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 24 months is below that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2023
First posted
Jan 26, 2023
StartActual
Mar 3, 2023
Primary completionActual
Mar 20, 2025
CompletionEst.
Dec 2038
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05699564
Collaborators
University of Oslo
Responsible party
Magnus Nakrem Lyngbakken (Associate professor, University Hospital, Akershus) — Principal investigator
First posted
Jan 26, 2023
Start date
Mar 3, 2023
Primary completion
Mar 20, 2025
Completion
Dec 2038 (estimated)
Last update
Apr 28, 2026

Study contacts

Magnus N Lyngbakken, MD PhD
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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