An observational study in Acute Heart Failure (AHF) and Heart Failure, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Sakarya University · Observational
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 128 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the emergency department of a tertiary care training and research hospital with signs and symptoms of acute heart failure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (older than 18 years) presenting to the emergency department with signs and symptoms of acute heart failure.
Diagnostic Test: Point-of-Care Ultrasound (POCUS) Protocol
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.
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.
Time frame: 30 days after ED admission
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.
Time frame: 30 days after ED admission
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in May 2025, 7 months.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 7 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.