NCT05699564Active, not recruiting
Akershus Cardiac Examination 4 Study
Akershus Cardiac Examination (ACE) 4 Study: Pragmatic Randomized Controlled Trial of Early Biomarker Measurements and Structured Feedback in Unselected Patients With Tachypnea
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 574 (actual)
- First submitted
- 5 Jan 2023
- Start date
- 3 Mar 2023
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- University Hospital, Akershus
- Diseases
- Heart failure
- NCT number
- NCT05699564
What you commit to
- Study type: Interventional
- Participants enrolled: 574
- From 3 Mar 2023 to the primary completion date, 20 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Patients unwilling or unable to comply with the protocol, including Glasgow Coma Scale \<13 on the time of study inclusion
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.