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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of care | No Intervention | Routine standard of care according to the treating physician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Hospital length of stay during the index hospitalization | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing primary and secondary outcomes with patients stratified by concentrations of NT-proBNP measured at admission | We will assess all the primary and secondary outcomes of the study in patients stratified according to concentrations of NT-proBNP (< 300 ng/L, 300-449ng/L, 450-899ng/L, 900-1799ng/L, >1799ng/L) measured at admission of the index hospitalization | From admission to discharge of index hospitalization, assessed up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus N Lyngbakken, MD PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Lørenskog | 1478 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2023 | Mar 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Version 1.1 | Feb 9, 2026 | Feb 10, 2026 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Version 1.0 | Aug 22, 2023 | Feb 10, 2026 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D059246 | Tachypnea |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit during the index hospitalization |
| From admission to discharge of index hospitalization, assessed up to 12 months |
| 30-day all-cause readmission | 30-day all-cause readmission after discharge from index hospitalization | 30-days after discharge from index hospitalization |
| Time to all-cause readmission | Time to first all-cause readmission after discharge from index hospitalization | 12 months after discharge from index hospitalization |
| Number of all-cause readmission | Number of all-cause readmissions after discharge from index hospitalization | 12 months after discharge from index hospitalization |
| All-cause mortality | Time to all-cause mortality after discharge from index hospitalization | 12 months after discharge from index hospitalization |
| Total cost of hospitalization | Total cost of hospitalization | From admission to discharge of index hospitalization, assessed up to 12 months |
| All-cause mortality | All-cause mortality during the index hospitalization | From admission to discharge of index hospitalization, assessed up to 12 months |
| Difference in cardiac biomarker concentrations during index hospitalization | Difference in the cardiac troponin T and/or I and B-type natriuretic peptide and/or N-terminal pro-B-type natriuretic peptide concentrations from hospital admission to discharge | From admission to discharge of index hospitalization, assessed up to 12 months |
| Difference in guideline-defined medical therapy for heart failure | Difference in guideline-defined medical therapy for heart failure, as defined by international guidelines, at discharge after index hospitalization | From admission to discharge of index hospitalization, assessed up to 12 months |
| Cost-utility | Cost-utility for the intervention strategy | 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 | We will assess all the primary and secondary outcomes of the study in patients stratified according to concentrations of cardiac troponin T (<10ng/L, 10-89ng/L), >89ng/L) measured at admission of the index hospitalization | 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 | Using c-statistics, we will assess the diagnostic accuracy of the H2FPEF score assessed during index hospitalization to predict heart failure with preserved ejection fraction in the total cohort of study patients | From admission to discharge of index hospitalization, assessed up to 12 months |
| Assessing accuracy for HFA-PEFF score for diagnosing heart failure with preserved ejection fraction | Using c-statistics, we will assess the diagnostic accuracy of the HFA-PEFF score assessed during index hospitalization to predict heart failure with preserved ejection fraction in the total cohort of study patients | From admission to discharge of index hospitalization, assessed up to 12 months |
| Assessing accuracy for NT-proBNP measured at hospital admission for diagnosing heart failure with preserved ejection fraction | Using c-statistics, we will assess the diagnostic accuracy of continuous concentrations of NT-proBNP measured at hospital admission to predict heart failure with preserved ejection fraction in the total cohort of study patients | From admission to discharge of index hospitalization, assessed up to 12 months |
| Assessing accuracy for cardiac troponin T measured at hospital admission for diagnosing heart failure with preserved ejection fraction | Using c-statistics, we will assess the diagnostic accuracy of continuous concentrations of cardiac troponin T measured at hospital admission to predict heart failure with preserved ejection fraction in the total cohort of study patients | From admission to discharge of index hospitalization, assessed up to 12 months |
| Assessing primary and secondary outcomes in the subgroup of patients classified as hospitalized due to heart failure | We will assess all the primary and secondary outcomes of the study in the subgroup of patients with heart failure as the adjudicated cause of tachypnea. | From admission to discharge of index hospitalization, assessed up to 12 months |
| 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 | We will assess all the primary and secondary outcomes of the study 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 as the adjudicated cause of tachypnea. | From admission to discharge of index hospitalization, assessed up to 12 months |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |