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Heart FailureACE4NCT05699564

Akershus Cardiac Examination 4 Study

A study testing Early biomarker-based cardiological assessment in people with Heart Failure and Tachypnea, run by University Hospital, Akershus at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Tachypnea
What is being tested?
Early biomarker-based cardiological assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
1 siteNorway
Study dates
3 Mar 2023to Dec 2038
Phase
Interventional
Are there results?
Not yet: the study is under way

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 ≥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 informed consent during the initial phase of the hospitalization

Who cannot join

  • 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 life expectancy; 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Akershus University Hospital

    Lørenskog, Lørenskog, 1478

Other trials in Norway

About this study

Official title: Akershus Cardiac Examination (ACE) 4 Study: Pragmatic Randomized Controlled Trial of Early Biomarker Measurements and Structured Feedback in Unselected Patients With Tachypnea

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

Being tested
Early biomarker-based cardiological assessment
Keywords
biomarker, tachypnea, heart failure, echocardiography
Medical subject headings
Heart Failure, Tachypnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early biomarker-based cardiological assessmentOther

    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.

Study groups in NCT05699564
Study groupRoleWhat they receive
Early biomarker-based cardiological assessment and structured feedback in the EHRExperimentalWe 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.
Receives: Other: Early biomarker-based cardiological assessment
Standard of careNo interventionRoutine standard of care according to the treating physician

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after discharge from index hospitalization

Secondary outcomes (11)

  1. Hospital length of stay

    Hospital length of stay during the index hospitalization

    Measured: 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

    Measured: 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

    Measured: 30-days after discharge from index hospitalization

  4. Time to all-cause readmission

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

    Measured: 12 months after discharge from index hospitalization

  5. Number of all-cause readmission

    Number of all-cause readmissions after discharge from index hospitalization

    Measured: 12 months after discharge from index hospitalization

  6. All-cause mortality

    Time to all-cause mortality after discharge from index hospitalization

    Measured: 12 months after discharge from index hospitalization

  7. Total cost of hospitalization

    Total cost of hospitalization

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

  8. All-cause mortality

    All-cause mortality during the index hospitalization

    Measured: 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

    Measured: 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

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

  11. Cost-utility

    Cost-utility for the intervention strategy

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start3 Mar 2023
  3. Primary completion20 Mar 2025
  4. Study completionDec 2038 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05699564
Sponsor's protocol ID
2015/1273
Acronym
ACE4
Status last verified
Apr 2026
First submitted
5 Jan 2023
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Early biomarker-based cardiological assessment in people with Heart Failure and Tachypnea, run by University Hospital, Akershus at 1 site in Norway.

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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

This study is still under way. Results are not available in the source record yet.

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?

Composite of all-cause hospital readmission or all-cause mortality (time frame: 12 months after discharge from index hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05699564.

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 28 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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