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Active, Not Recruiting

NCT Number: NCT05699564

Akershus Cardiac Examination 4 Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital

Lørenskog, 1478, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent during the initial phase of the hospitalization

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 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
  • 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

Treatment and study plan

Early biomarker-based cardiological assessment

Other

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.

Primary outcomes

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

    Time frame: 12 months after discharge from index hospitalization

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

Secondary outcomes

  1. Hospital length of stay

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

    Hospital length of stay during the index hospitalization

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

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

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

  3. 30-day all-cause readmission

    Time frame: 30-days after discharge from index hospitalization

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

  4. Time to all-cause readmission

    Time frame: 12 months after discharge from index hospitalization

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

  5. Number of all-cause readmission

    Time frame: 12 months after discharge from index hospitalization

    Number of all-cause readmissions after discharge from index hospitalization

  6. All-cause mortality

    Time frame: 12 months after discharge from index hospitalization

    Time to all-cause mortality after discharge from index hospitalization

  7. Total cost of hospitalization

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

    Total cost of hospitalization

  8. All-cause mortality

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

    All-cause mortality during the index hospitalization

  9. Difference in cardiac biomarker concentrations during index hospitalization

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

    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

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

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

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

  11. Cost-utility

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

    Cost-utility for the intervention strategy

Other outcomes

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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.

  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

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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Acronym: ACE4

Important dates

Study start
2023
Primary completion
2025
Study completion
2038
First posted
Jan 26, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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