search
Back to results

Akershus Cardiac Examination 4 Study (ACE4)

Primary Purpose

Heart Failure, Tachypnea

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early biomarker-based cardiological assessment
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring biomarker, tachypnea, heart failure, echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Akershus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Standard of care

Arm 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.

Routine standard of care according to the treating physician

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital length of stay
Hospital length of stay during the index hospitalization
Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit
Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit during the index hospitalization
30-day all-cause readmission
30-day all-cause readmission after discharge from index hospitalization
Time to all-cause readmission
Time to first all-cause readmission after discharge from index hospitalization
Number of all-cause readmission
Number of all-cause readmissions after discharge from index hospitalization
All-cause mortality
Time to all-cause mortality after discharge from index hospitalization
Total cost of hospitalization
Total cost of hospitalization
All-cause mortality
All-cause mortality during the index hospitalization
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
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
Cost-utility
Cost-utility for the intervention strategy

Full Information

First Posted
January 5, 2023
Last Updated
March 3, 2023
Sponsor
University Hospital, Akershus
Collaborators
University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT05699564
Brief Title
Akershus Cardiac Examination 4 Study
Acronym
ACE4
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2038 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Tachypnea
Keywords
biomarker, tachypnea, heart failure, echocardiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early biomarker-based cardiological assessment and structured feedback in the EHR
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Routine standard of care according to the treating physician
Intervention Type
Other
Intervention Name(s)
Early biomarker-based cardiological assessment
Intervention 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.
Primary Outcome Measure Information:
Title
Composite of all-cause hospital readmission or all-cause mortality
Description
Composite of all-cause hospital readmission or all-cause mortality after discharge from index hospitalization
Time Frame
12 months after discharge from index hospitalization
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
Hospital length of stay during the index hospitalization
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit
Description
Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit during the index hospitalization
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
30-day all-cause readmission
Description
30-day all-cause readmission after discharge from index hospitalization
Time Frame
30-days after discharge from index hospitalization
Title
Time to all-cause readmission
Description
Time to first all-cause readmission after discharge from index hospitalization
Time Frame
12 months after discharge from index hospitalization
Title
Number of all-cause readmission
Description
Number of all-cause readmissions after discharge from index hospitalization
Time Frame
12 months after discharge from index hospitalization
Title
All-cause mortality
Description
Time to all-cause mortality after discharge from index hospitalization
Time Frame
12 months after discharge from index hospitalization
Title
Total cost of hospitalization
Description
Total cost of hospitalization
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
All-cause mortality
Description
All-cause mortality during the index hospitalization
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Difference in cardiac biomarker concentrations during index hospitalization
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Difference in guideline-defined medical therapy for heart failure
Description
Difference in guideline-defined medical therapy for heart failure, as defined by international guidelines, at discharge after index hospitalization
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Cost-utility
Description
Cost-utility for the intervention strategy
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Other Pre-specified Outcome Measures:
Title
Assessing primary and secondary outcomes with patients stratified by concentrations of NT-proBNP measured at admission
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing primary and secondary outcomes with patients stratified by concentrations of cardiac troponin T measured at admission
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing accuracy for HF2FPEF score assessed during index hospitalization for diagnosing heart failure with preserved ejection fraction
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing accuracy for HFA-PEFF score for diagnosing heart failure with preserved ejection fraction
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing accuracy for NT-proBNP measured at hospital admission for diagnosing heart failure with preserved ejection fraction
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing accuracy for cardiac troponin T measured at hospital admission for diagnosing heart failure with preserved ejection fraction
Description
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
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
Assessing primary and secondary outcomes in the subgroup of patients classified as hospitalized due to heart failure
Description
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.
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months
Title
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
Description
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.
Time Frame
From admission to discharge of index hospitalization, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus N Lyngbakken, MD PhD
Phone
+4793408837
Email
magnus.lyngbakken@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Helge Røsjø, MD PhD
Phone
+4791545864
Email
helge.rosjo@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus N Lyngbakken, MD PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnus N Lyngbakken, MD PhD
Phone
+4793408837
Email
magnus.lyngbakken@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Helge Røsjø, MD PhD
Phone
+4791545864
Email
helge.rosjo@medisin.uio.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Akershus Cardiac Examination 4 Study

We'll reach out to this number within 24 hrs