Akershus Cardiac Examination 4 Study

NCT ID: NCT05699564

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2038-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early biomarker-based cardiological assessment

Intervention Type: 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.

Standard of care

Routine standard of care according to the treating physician

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Magnus Nakrem Lyngbakken

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus N Lyngbakken, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lørenskog, , Norway

Countries

Norway

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015/1273

Identifier Type: -

Identifier Source: org_study_id