Akershus Cardiac Examination 4 Study (ACE4)

University Hospital, Akershus

Status: Active, not recruiting

Conditions: Tachypnea; Heart Failure

Treatments: Other: Early biomarker-based cardiological assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05699564

2015/1273

Details and patient eligibility

About

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

Enrollment: 574 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

574 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Early biomarker-based cardiological assessment

Standard of care

No Intervention group

Description:

Routine standard of care according to the treating physician