Akershus Cardiac Examination 4 Study

NCT05699564 | Active Not Recruiting DMC

• 1 other identifier: 2015/1273
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Heart Failure; Tachypnea

Keywords

biomarker; tachypnea; heart failure; echocardiography

Outcome Measures

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

  12 months after discharge from index hospitalization

Secondary Outcomes (11)

• Hospital length of stay

  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

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

• 30-day all-cause readmission

  30-days after discharge from index hospitalization

• Time to all-cause readmission

  12 months after discharge from index hospitalization

• Number of all-cause readmission

  12 months after discharge from index hospitalization

Other Outcomes (8)

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

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

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

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

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

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

Study Arms (2)

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

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

Routine standard of care according to the treating physician

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed written informed consent during the initial phase of the hospitalization

You may not qualify if:

• Previously included into the study (in case of patients presenting with a second hospitalization during the study period)
• 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 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Lørenskog, 1478, Norway

Location

MeSH Terms

Conditions

Heart Failure; Tachypnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Magnus N Lyngbakken, MD PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: March 3, 2023
• Primary Completion: March 20, 2025
• Study Completion (Estimated): December 1, 2038
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)