Cardiovascular DiseasesPOCUS-HFNCT06887179
Point-of-Care Ultrasound in Chronic Heart Failure
A study testing HF focused POCUS in people with Cardiovascular Diseases, run by Masaryk University at 1 site in Czechia.
Trial summary
This study aims to determine whether Point-of-Care Ultrasound (POCUS)-guided treatment is non-inferior to standard NT-proBNP-based care in ambulatory patients following hospitalization for heart failure (HF) over a 12-month follow-up period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- HF focused POCUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients after hospitalization for acute heart failure (AHF)
- Symptoms (shortness of breath, oedema, decreased exercise tolerance, increase in abdominal circumference)
- Clinical signs (jugular vein distention, hepatojugular reflux, third heart sound, wet lung crackles, pitting oedema) or signs of congestion on CT, X-ray or ultrasound
- NT-proBNP >450 pg/mL <55 years old, >900 pg/mL 55-75 years old, >1800 pg/mL >75 years old
- Increase in oral diuretic therapy or need for IV diuretics
Who cannot join
- pregnancy or lactation
- under 18 years of age,
- current AHF due to a transient cause (Takotsubo syndrome, neurogenic myocardial stunning, septic cardiomyopathy, cardiac tamponade, pulmonary embolism with acute cor pulmonale, thyrotoxicosis, bradycardia <40/min)
- planned surgical treatment of the HF cause, CRT implantation or valvular repair ≤ 30 days ago, STEMI or coronary angiography with PCI or CABG ≤ 30 days ago, untreated AV block III. and II. degree type 2, planned or previous heart transplantation, myocarditis ≤ 6 months ago, complex congenital heart disease, cardiac amyloidosis, hypertrophic and restrictive cardiomyopathy, constrictive pericarditis
- BMI over 40 kg/m2, cognitive deficit with MMSE <18 points, life expectancy < 12 months, progressive oncological disease, chronic liver failure Child-Pugh C, chronic kidney disease with eGFR <0.25 ml/s
- current participation in another study or relative of investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Brno
Brno, 625 00
Ondrej Ludka, Prof., +420 532 231 976, ludka.ondrej@fnbrno.cz
Adam Koudelka, MD, +420 532 231 873, koudelka.adam@fnbrno.cz
About this study
Official title: The Role of Point-of-Care Ultrasound in the Management of Chronic Heart Failure
This study aims to determine whether Point-of-Care Ultrasound (POCUS)-guided treatment is non-inferior to standard NT-proBNP-based care in ambulatory patients following hospitalization for heart failure (HF) over a 12-month follow-up period.
Read the detailed description
Although ultrasound machines are routinely available in ambulatory settings these days, assessing congestion with POCUS during regular visits is not yet established as a standard of care for HF patients. Accurate assessment of congestion is a cornerstone in managing HF since congestion is a major driver of symptoms, hospitalizations, and adverse outcomes. Current standard methods for congestion assessment include clinical examination, laboratory markers such as NT-proBNP, chest X-ray, and sometimes invasive hemodynamic monitoring. However, these approaches have limitations: clinical signs can be subjective, NT-proBNP levels may be influenced by non-cardiac factors, and invasive monitoring is not feasible for routine outpatient use. Chest X-ray bears the risk of irradiation and is more time and money-consuming than bedside tools.
POCUS has emerged as a promising tool for real-time congestion assessment. It allows for direct visualization of pulmonary and systemic congestion, providing rapid bedside insights into the patient's volume status (9). Despite its advantages, POCUS is not yet widely implemented in routine HF ambulatory management, primarily due to the lack of standardized protocols with sufficient evidence.
This study evaluates whether an HF-focused POCUS protocol can enhance congestion assessment in ambulatory HF patients following hospitalization. During a follow-up period of 12 months, they will be regularly examined clinically and with standard laboratory tests. HF-focused POCUS will be performed in the interventional arm instead of standard NT-proBNP testing. For the sake of simplicity and practicality of the examination, a handheld ultrasound device (GE Healthcare Vscan Air SL® or Vscan Extend®) with only a sector probe in B-mode will be employed.
The HF-focused POCUS examination includes several predefined components. Lung assessment to detect pulmonary congestion. Pleural assessment to detect congestion with effusion. The inferior vena cava assessment is used to estimate central venous pressure. The presence of ascites is evaluated by scanning the hepatorenal space and right paracolic gutter for signs of fluid accumulation.
The HF-focused POCUS is performed by treating physicians, allowing immediate diuretic therapy adjustments based on the results. The hypothesis is that HF-focused POCUS can enable more precise diuretic titration, potentially reducing adverse events.
- Conditions
- Cardiovascular Diseases
- Being tested
- HF focused POCUS, Standard Care (in control arm)
- Keywords
- Heart failure, Diuretic therapy, Congestion, Point-of-Care Ultrasound
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF focused POCUSProcedure or surgery
- POCUS findings guide diuretic therapy adjustments by treating physicians
- POCUS is performed with handheld device Vscan air SL® or Vscan extend®, GE Healthcare.
- Sector probe and abdominal preset are used. Only B-mode is used.
- The image depth is 15 cm or more to evaluate the structures sufficiently.
- Patient position is supine or semirecumbent. For the pleural effusion exam, the preferred position is sitting.
- Lungs: Assessment of B-lines in midclavicular and midaxillary zones.
- Pleural Effusion
- Inferior Vena Cava
- Ascites
Standard Care (in control arm)Procedure or surgery
Standard care assessment with NT-proBNP on every scheduled visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | * Echocardiography in index hospitalization (left ventricle ejection fraction, E/e' ratio, LAVi, TAPSE, peak systolic tricuspid annular velocity, peak tricuspid regurgitation velocity, estimated pulmonary artery systolic pressure)
* Mini-Mental State Examination in index hospitalization in 65 years and older
* Clinical examination, blood pressure, heart rate, oxygen saturation, ECG, height, weight, BMI, NYHA on every visit
* KCCQ in first week visit and 12 months visit
* Blood tests:
* NT-proBNP in index hospitalization and 12 months visit
* blood count, urea, creatinine, glycaemia and electrolytes on every visit
* HF focused POCUS on every visit Receives: Procedure: HF focused POCUS |
| Standard care arm | Active comparator | * Echocardiography in index hospitalization (left ventricle ejection fraction, E/e' ratio, LAVi, TAPSE, peak systolic tricuspid annular velocity, peak tricuspid regurgitation velocity, estimated pulmonary artery systolic pressure)
* Mini-Mental State Examination in index hospitalization in 65 years and older
* Clinical examination, blood pressure, heart rate, oxygen saturation, ECG, height, weight, BMI, NYHA on every visit
* KCCQ in first-week visit and 12 months visit
* Blood tests:
* NT-proBNP in index hospitalization and on every scheduled visit
* blood count, urea, creatinine, glycaemia and electrolytes on every visit Receives: Procedure: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome
The primary outcome is a composite of urgent visits, hospitalization for worsening HF and death from any cause. We defined an urgent visit for worsening HF as an unscheduled visit because of signs and/or symptoms of worsening HF that require IV diuretic treatment or a diuretic increase with a hospital stay of less than 24 hours. Hospitalization for worsening HF is defined as a stay in hospital for more than 24 hours because of signs and/or symptoms of worsening HF.
Measured: 12 months
Secondary outcomes (11)
The number of all AHF hospitalizations
The total number of all AHF hospitalizations
Measured: 12 months
The number of other unplanned hospitalizations
The total number of other unplanned hospitalizations
Measured: 12 months
The number of all unscheduled visits for any cause
The total number of all unscheduled visits for any cause
Measured: 12 months
The number of extra visits beyond the protocol schedule for HF treatment
The total number of extra visits beyond the protocol schedule for HF treatment
Measured: 12 months
The change in NT-proBNP
The change in NT-proBNP (ng/l)
Measured: 12 months
The change in eGFR
The change in eGFR (ml/s/1,73m2)
Measured: 12 months
The change in Kansas City Cardiomyopathy Questionnaire
The change in KCCQ (points). It is scored from 0 to 100 with higher scores indicating better health status.
Measured: 12 months
The number of performed chest X-rays
The total number of performed chest X-rays
Measured: 12 months
The number of drainage procedures for fluidothorax or ascites.
The total number of drainage procedures for fluidothorax or ascites.
Measured: 12 months
Safety outcome
Diuretics-related decrease in eGFR >50% (with signs of hypovolemia) compared to the 1st-week visit value; the level of hypokalemia <3.5 mmol/L (the number of patients having hypokalemia <3.5 mmol/L).
Measured: 12 months
The level of hypokalemia <3.5 mmol/L
The number of patients having hypokalemia <3.5 mmol/L
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, open-label, intention-to-treat, prospective clinical trial. It compares ambulatory patients following hospitalization for heart failure in the standard care treatment arm with the intervention arm treated according to the HF-focused POCUS results done by the treating physician.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Ondrej Ludka, Prof., Study chair, Brno University HospitalOndrej Ludka, Prof., Study director, Brno University HospitalAdam Koudelka, MD, Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887179
- Sponsor's protocol ID
- POCUS-HF-FNBrno
- Acronym
- POCUS-HF
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Point-of-Care Ultrasound in the Management of Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06887179
- Acronym / sponsor ID
- POCUS-HF / POCUS-HF-FNBrno
- Conditions
- Cardiovascular Diseases
- Keywords
- Heart failure, Diuretic therapy, Congestion, Point-of-Care Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Mar 2025 (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.
This study aims to determine whether Point-of-Care Ultrasound (POCUS)-guided treatment is non-inferior to standard NT-proBNP-based care in ambulatory patients following hospitalization for heart failure (HF) over a 12-month follow-up period.
Detailed description
Although ultrasound machines are routinely available in ambulatory settings these days, assessing congestion with POCUS during regular visits is not yet established as a standard of care for HF patients. Accurate assessment of congestion is a cornerstone in managing HF since congestion is a major driver of symptoms, hospitalizations, and adverse outcomes. Current standard methods for congestion assessment include clinical examination, laboratory markers such as NT-proBNP, chest X-ray, and sometimes invasive hemodynamic monitoring. However, these approaches have limitations: clinical signs can be subjective, NT-proBNP levels may be influenced by non-cardiac factors, and invasive monitoring is not feasible for routine outpatient use. Chest X-ray bears the risk of irradiation and is more time and money-consuming than bedside tools.
POCUS has emerged as a promising tool for real-time congestion assessment. It allows for direct visualization of pulmonary and systemic congestion, providing rapid bedside insights into the patient's volume status (9). Despite its advantages, POCUS is not yet widely implemented in routine HF ambulatory management, primarily due to the lack of standardized protocols with sufficient evidence.
This study evaluates whether an HF-focused POCUS protocol can enhance congestion assessment in ambulatory HF patients following hospitalization. During a follow-up period of 12 months, they will be regularly examined clinically and with standard laboratory tests. HF-focused POCUS will be performed in the interventional arm instead of standard NT-proBNP testing. For the sake of simplicity and practicality of the examination, a handheld ultrasound device (GE Healthcare Vscan Air SL® or Vscan Extend®) with only a sector probe in B-mode will be employed.
The HF-focused POCUS examination includes several predefined components. Lung assessment to detect pulmonary congestion. Pleural assessment to detect congestion with effusion. The inferior vena cava assessment is used to estimate central venous pressure. The presence of ascites is evaluated by scanning the hepatorenal space and right paracolic gutter for signs of fluid accumulation.
The HF-focused POCUS is performed by treating physicians, allowing immediate diuretic therapy adjustments based on the results. The hypothesis is that HF-focused POCUS can enable more precise diuretic titration, potentially reducing adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized, open-label, intention-to-treat, prospective clinical trial. It compares ambulatory patients following hospitalization for heart failure in the standard care treatment arm with the intervention arm treated according to the HF-focused POCUS results done by the treating physician.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Procedure: HF focused POCUS* Echocardiography in index hospitalization (left ventricle ejection fraction, E/e' ratio, LAVi, TAPSE, peak systolic tricuspid annular velocity, peak tricuspid regurgitation velocity, estimated pulmonary artery systolic pressure) * Mini-Mental State Examination in index hospitalization in 65 years and older * Clinical examination, blood pressure, heart rate, oxygen saturation, ECG, height, weight, BMI, NYHA on every visit * KCCQ in first week visit and 12 months visit * Blood tests: * NT-proBNP in index hospitalization and 12 months visit * blood count, urea, creatinine, glycaemia and electrolytes on every visit * HF focused POCUS on every visit |
| Standard care arm | Active comparator | Procedure: Standard Care (in control arm)* Echocardiography in index hospitalization (left ventricle ejection fraction, E/e' ratio, LAVi, TAPSE, peak systolic tricuspid annular velocity, peak tricuspid regurgitation velocity, estimated pulmonary artery systolic pressure) * Mini-Mental State Examination in index hospitalization in 65 years and older * Clinical examination, blood pressure, heart rate, oxygen saturation, ECG, height, weight, BMI, NYHA on every visit * KCCQ in first-week visit and 12 months visit * Blood tests: * NT-proBNP in index hospitalization and on every scheduled visit * blood count, urea, creatinine, glycaemia and electrolytes on every visit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients after hospitalization for acute heart failure (AHF)
- Symptoms (shortness of breath, oedema, decreased exercise tolerance, increase in abdominal circumference)
- Clinical signs (jugular vein distention, hepatojugular reflux, third heart sound, wet lung crackles, pitting oedema) or signs of congestion on CT, X-ray or ultrasound
- NT-proBNP >450 pg/mL <55 years old, >900 pg/mL 55-75 years old, >1800 pg/mL >75 years old
- Increase in oral diuretic therapy or need for IV diuretics
Key exclusion criteria (6 listed)
- pregnancy or lactation
- under 18 years of age,
- current AHF due to a transient cause (Takotsubo syndrome, neurogenic myocardial stunning, septic cardiomyopathy, cardiac tamponade, pulmonary embolism with acute cor pulmonale, thyrotoxicosis, bradycardia <40/min)
- planned surgical treatment of the HF cause, CRT implantation or valvular repair ≤ 30 days ago, STEMI or coronary angiography with PCI or CABG ≤ 30 days ago, untreated AV block III. and II. degree type 2, planned or previous heart transplantation, myocarditis ≤ 6 months ago, complex congenital heart disease, cardiac amyloidosis, hypertrophic and restrictive cardiomyopathy, constrictive pericarditis
- BMI over 40 kg/m2, cognitive deficit with MMSE <18 points, life expectancy < 12 months, progressive oncological disease, chronic liver failure Child-Pugh C, chronic kidney disease with eGFR <0.25 ml/s
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 |
|---|---|---|
| HF focused POCUS* POCUS findings guide diuretic therapy adjustments by treating physicians * POCUS is performed with handheld device Vscan air SL® or Vscan extend®, GE Healthcare. * Sector probe and abdominal preset are used. Only B-mode is used. * The image depth is 15 cm or more to evaluate the structures sufficiently. * Patient position is supine or semirecumbent. For the pleural effusion exam, the preferred position is sitting. 1. Lungs: Assessment of B-lines in midclavicular and midaxillary zones. 2. Pleural Effusion 3. Inferior Vena Cava 4. Ascites | Procedure or surgery | Intervention Arm |
| Standard Care (in control arm)Standard care assessment with NT-proBNP on every scheduled visit. | Procedure or surgery | Standard care arm |
Primary outcome
The primary outcome
Time frame: 12 months
The primary outcome is a composite of urgent visits, hospitalization for worsening HF and death from any cause. We defined an urgent visit for worsening HF as an unscheduled visit because of signs and/or symptoms of worsening HF that require IV diuretic treatment or a diuretic increase with a hospital stay of less than 24 hours. Hospitalization for worsening HF is defined as a stay in hospital for more than 24 hours because of signs and/or symptoms of worsening HF.
11 secondary outcomes
The number of all AHF hospitalizations
Time frame: 12 months
The number of other unplanned hospitalizations
Time frame: 12 months
The number of all unscheduled visits for any cause
Time frame: 12 months
The number of extra visits beyond the protocol schedule for HF treatment
Time frame: 12 months
The change in NT-proBNP
Time frame: 12 months
The change in eGFR
Time frame: 12 months
The change in Kansas City Cardiomyopathy Questionnaire
Time frame: 12 months
The number of performed chest X-rays
Time frame: 12 months
The number of drainage procedures for fluidothorax or ascites.
Time frame: 12 months
Safety outcome
Time frame: 12 months
The level of hypokalemia <3.5 mmol/L
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Ondrej Ludka, Prof. study chair
Brno University Hospital
Ondrej Ludka, Prof. study director
Brno University Hospital
Adam Koudelka, MD principal investigator
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF focused POCUS in people with Cardiovascular Diseases, run by Masaryk University at 1 site in Czechia.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Koudelka, MD (+420 532 231 873, koudelka.adam@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome (time frame: 12 months). 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 25 Mar 2025.