Acute Heart Failure (AHF)NCT07905443
Bedside Ultrasound in the Emergency Department for Predicting Acute Heart Failure Outcomes
An observational study of Acute Heart Failure (AHF) and Heart Failure, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Acute heart failure is a common and serious condition that frequently brings patients to the emergency department. Emergency physicians need quick and reliable methods to evaluate the severity of the condition and monitor the response to initial treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Heart Failure
- What is being tested?
- Point-of-Care Ultrasound (POCUS) Protocol
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2024to 15 Jul 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the emergency department of a tertiary care training and research hospital with signs and symptoms of acute heart failure.
Who may be able to join
- Patients presenting to the emergency department with signs and symptoms of acute heart failure.
- Age older than 18 years.
- Patients admitted during the working hours of the principal investigator.
Who cannot join
- Presence of interstitial lung disease.
- Acute renal failure or being on a routine dialysis program.
- Diagnosis of acute coronary syndrome.
- Requirement for intubation.
- Diagnosis of pneumonia or acute exacerbation of chronic obstructive pulmonary disease in the emergency department.
- Altered mental status / confusion.
- Pregnancy.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54100
About this study
Official title: The Role of Point-of-care Ultrasound Protocols in Predicting Clinical Outcomes, Readmission, and Mortality in Patients Presenting to the Emergency Department With Acute Heart Failure
Acute heart failure is a common and serious condition that frequently brings patients to the emergency department. Emergency physicians need quick and reliable methods to evaluate the severity of the condition and monitor the response to initial treatment. This observational study aims to evaluate the effectiveness of bedside ultrasound (Point-of-Care Ultrasound or POCUS) in predicting clinical outcomes for these patients. Researchers will perform bedside ultrasound scans on adult patients presenting with acute heart failure. The scans will be performed twice: first upon admission to the emergency department, and again three hours after starting treatment. The ultrasound protocol will check the heart's pumping ability, look for fluid in the lungs, and measure specific veins (inferior vena cava and internal jugular vein) to assess fluid overload. The main goal of this study is to see if these ultrasound measurements can successfully predict important patient outcomes, including the likelihood of returning to the hospital within 30 days and 30-day survival.
Read the detailed description
Acute heart failure (AHF) is a leading cause of emergency department (ED) visits, characterized by high morbidity, mortality, and frequent readmissions. One of the main challenges in the ED management of AHF is accurately determining the severity of systemic and pulmonary congestion to guide treatment. While standard clinical assessments have limitations, Point-of-Care Ultrasound (POCUS) has emerged as a dynamic, non-invasive tool to holistically evaluate congestion. This is a single-center, prospective observational study designed to evaluate the predictive value of a comprehensive POCUS protocol in AHF patients. Upon ED presentation and AHF diagnosis, enrolled patients will be managed by their primary emergency physicians according to standard clinical guidelines. To prevent bias, the primary treating physicians will be completely blinded to the research POCUS findings, and the principal investigator will not interfere with the clinical decision-making or treatment process. The principal investigator will perform the comprehensive POCUS evaluation at two specific time points: immediately upon admission (simultaneously with the initiation of medical treatment) and three hours after treatment initiation. The bedside ultrasound protocol will consist of four main components: 1. Transthoracic Echocardiography: Measurement of Left Ventricular Ejection Fraction (LVEF) using Simpson's biplane method. 2. Lung Ultrasound: Application of the BLUE protocol to assess B-lines at 8 specific anatomical points and evaluate the presence and size of pleural effusion at the PLAPS point. 3. Inferior Vena Cava (IVC) Ultrasound: Measurement of maximum and minimum diameters and calculation of the collapsibility index. 4. Internal Jugular Vein (IJV) Ultrasound: Measurement of maximum diameter (during Valsalva maneuver) and minimum diameter (at end-expiration) to calculate the distensibility ratio. Following the ED observation period, patient outcomes will be tracked. In-hospital mortality for admitted patients will be recorded via the hospital information system. Discharged patients will be followed up via telephone calls on days 7 and 30 to assess for any hospital readmissions and 30-day mortality.
- Conditions
- Acute Heart Failure (AHF), Heart Failure
- Being tested
- Point-of-Care Ultrasound (POCUS) Protocol
- Keywords
- Point-of-Care Ultrasound, POCUS, Emergency Department, Mortality, Prognosis, Lung Ultrasound
- Medical subject headings
- Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care Ultrasound (POCUS) ProtocolDiagnostic test
A comprehensive bedside ultrasound protocol consisting of Left Ventricular Ejection Fraction (LVEF) measurement, lung ultrasound (BLUE protocol), Inferior Vena Cava (IVC) ultrasound, and Internal Jugular Vein (IJV) ultrasound. The protocol is performed twice: at admission and 3 hours after treatment initiation.
| Study group | Role | What they receive |
|---|---|---|
| Acute Heart Failure Patients | Adult patients (older than 18 years) presenting to the emergency department with signs and symptoms of acute heart failure. Receives: Diagnostic Test: Point-of-Care Ultrasound (POCUS) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day All-Cause Mortality
The number of patients who died from any cause within 30 days of their initial emergency department presentation, assessed via hospital records or telephone follow-up.
Measured: 30 days after ED admission
Secondary outcomes (1)
30-Day Hospital Readmission Rate
The number of patients who require a subsequent, unplanned hospital visit or readmission due to acute heart failure exacerbation or related cardiovascular events within 30 days of their initial emergency department presentation.
Measured: 30 days after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start11 Oct 2024
- Primary completion29 May 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yusuf Yürümez, Prof. Dr., Principal investigator, Sakarya University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905443
- Sponsor's protocol ID
- E-43012747-050.04-399628-50
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to strict patient privacy and confidentiality agreements. The informed consent form, approved by the local Ethics Committee, explicitly states that individual patient data will remain strictly confidential and will not be shared with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Point-of-care Ultrasound Protocols in Predicting Clinical Outcomes, Readmission, and Mortality in Patients Presenting to the Emergency Department With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07905443
- Acronym / sponsor ID
- E-43012747-050.04-399628-50
- Conditions
- Acute Heart Failure (AHF), Heart Failure
- Keywords
- Point-of-Care Ultrasound, POCUS, Emergency Department, Mortality, Prognosis, Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute heart failure is a common and serious condition that frequently brings patients to the emergency department. Emergency physicians need quick and reliable methods to evaluate the severity of the condition and monitor the response to initial treatment. This observational study aims to evaluate the effectiveness of bedside ultrasound (Point-of-Care Ultrasound or POCUS) in predicting clinical outcomes for these patients. Researchers will perform bedside ultrasound scans on adult patients presenting with acute heart failure. The scans will be performed twice: first upon admission to the emergency department, and again three hours after starting treatment. The ultrasound protocol will check the heart's pumping ability, look for fluid in the lungs, and measure specific veins (inferior vena cava and internal jugular vein) to assess fluid overload. The main goal of this study is to see if these ultrasound measurements can successfully predict important patient outcomes, including the likelihood of returning to the hospital within 30 days and 30-day survival.
Detailed description
Acute heart failure (AHF) is a leading cause of emergency department (ED) visits, characterized by high morbidity, mortality, and frequent readmissions. One of the main challenges in the ED management of AHF is accurately determining the severity of systemic and pulmonary congestion to guide treatment. While standard clinical assessments have limitations, Point-of-Care Ultrasound (POCUS) has emerged as a dynamic, non-invasive tool to holistically evaluate congestion. This is a single-center, prospective observational study designed to evaluate the predictive value of a comprehensive POCUS protocol in AHF patients. Upon ED presentation and AHF diagnosis, enrolled patients will be managed by their primary emergency physicians according to standard clinical guidelines. To prevent bias, the primary treating physicians will be completely blinded to the research POCUS findings, and the principal investigator will not interfere with the clinical decision-making or treatment process. The principal investigator will perform the comprehensive POCUS evaluation at two specific time points: immediately upon admission (simultaneously with the initiation of medical treatment) and three hours after treatment initiation. The bedside ultrasound protocol will consist of four main components: 1. Transthoracic Echocardiography: Measurement of Left Ventricular Ejection Fraction (LVEF) using Simpson's biplane method. 2. Lung Ultrasound: Application of the BLUE protocol to assess B-lines at 8 specific anatomical points and evaluate the presence and size of pleural effusion at the PLAPS point. 3. Inferior Vena Cava (IVC) Ultrasound: Measurement of maximum and minimum diameters and calculation of the collapsibility index. 4. Internal Jugular Vein (IJV) Ultrasound: Measurement of maximum diameter (during Valsalva maneuver) and minimum diameter (at end-expiration) to calculate the distensibility ratio. Following the ED observation period, patient outcomes will be tracked. In-hospital mortality for admitted patients will be recorded via the hospital information system. Discharged patients will be followed up via telephone calls on days 7 and 30 to assess for any hospital readmissions and 30-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Heart Failure Patients | – | Diagnostic Test: Point-of-Care Ultrasound (POCUS) ProtocolAdult patients (older than 18 years) presenting to the emergency department with signs and symptoms of acute heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the emergency department of a tertiary care training and research hospital with signs and symptoms of acute heart failure.
Key inclusion criteria (3 listed)
- Patients presenting to the emergency department with signs and symptoms of acute heart failure.
- Age older than 18 years.
- Patients admitted during the working hours of the principal investigator.
Key exclusion criteria (8 listed)
- Presence of interstitial lung disease.
- Acute renal failure or being on a routine dialysis program.
- Diagnosis of acute coronary syndrome.
- Requirement for intubation.
- Diagnosis of pneumonia or acute exacerbation of chronic obstructive pulmonary disease in the emergency department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care Ultrasound (POCUS) ProtocolA comprehensive bedside ultrasound protocol consisting of Left Ventricular Ejection Fraction (LVEF) measurement, lung ultrasound (BLUE protocol), Inferior Vena Cava (IVC) ultrasound, and Internal Jugular Vein (IJV) ultrasound. The protocol is performed twice: at admission and 3 hours after treatment initiation. | Diagnostic test | Acute Heart Failure Patients |
Primary outcome
30-Day All-Cause Mortality
Time frame: 30 days after ED admission
The number of patients who died from any cause within 30 days of their initial emergency department presentation, assessed via hospital records or telephone follow-up.
1 secondary outcome
30-Day Hospital Readmission Rate
Time frame: 30 days after ED admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to strict patient privacy and confidentiality agreements. The informed consent form, approved by the local Ethics Committee, explicitly states that individual patient data will remain strictly confidential and will not be shared with third parties.
Related trials for Acute Heart Failure (AHF)
RecruitingObservational study
Comprehensive Clinical Prediction Rule for Acute Heart Failure
Acute Heart Failure (AHF)
Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Not yet recruiting
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF)
Acute Heart Failure (AHF)
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Yürümez, Prof. Dr. principal investigator
Sakarya University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF) and Heart Failure, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day All-Cause Mortality (time frame: 30 days after ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.