Clinical trial NCT05699564: Akershus Cardiac Examination 4 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Tachypnea
Keywords: biomarker
tachypnea
heart failure
echocardiography
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2023-01-26
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Composite of all-cause hospital readmission or all-cause mortality
timeFrame: 12 months after discharge from index hospitalization
Secondary outcomes:
measure: Hospital length of stay
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: 30-day all-cause readmission
timeFrame: 30-days after discharge from index hospitalization
measure: Time to all-cause readmission
timeFrame: 12 months after discharge from index hospitalization
measure: Number of all-cause readmission
timeFrame: 12 months after discharge from index hospitalization
measure: All-cause mortality
timeFrame: 12 months after discharge from index hospitalization
measure: Total cost of hospitalization
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: All-cause mortality
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Difference in cardiac biomarker concentrations during index hospitalization
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Difference in guideline-defined medical therapy for heart failure
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Cost-utility
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
Other outcomes:
measure: Assessing primary and secondary outcomes with patients stratified by concentrations of NT-proBNP measured at admission
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing primary and secondary outcomes with patients stratified by concentrations of cardiac troponin T measured at admission
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing accuracy for HF2FPEF score assessed during index hospitalization for diagnosing heart failure with preserved ejection fraction
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing accuracy for HFA-PEFF score for diagnosing heart failure with preserved ejection fraction
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing accuracy for NT-proBNP measured at hospital admission for diagnosing heart failure with preserved ejection fraction
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing accuracy for cardiac troponin T measured at hospital admission for diagnosing heart failure with preserved ejection fraction
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: Assessing primary and secondary outcomes in the subgroup of patients classified as hospitalized due to heart failure
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
measure: 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
timeFrame: From admission to discharge of index hospitalization, assessed up to 12 months
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Magnus N Lyngbakken, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: