Point-of-Care Ultrasound in Chronic Heart Failure

NCT ID: NCT06887179

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention 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 12 months visit
• blood count, urea, creatinine, glycaemia and electrolytes on every visit
• HF focused POCUS on every visit

Group Type: EXPERIMENTAL

HF focused POCUS

Intervention Type: PROCEDURE

• 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

Standard care 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

Group Type: ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type: PROCEDURE

Standard care assessment with NT-proBNP on every scheduled visit.

Interventions

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

Intervention Type: PROCEDURE

Standard Care (in control arm)

Standard care assessment with NT-proBNP on every scheduled visit.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Brno

UNKNOWN

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ondrej Ludka, Prof.

Role: STUDY_CHAIR

University Hospital Brno

Ondrej Ludka, Prof.

Role: STUDY_DIRECTOR

University Hospital Brno

Adam Koudelka, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Locations

University Hospital Brno

Brno, , Czechia

Countries

Czechia

Central Contacts

Adam Koudelka, MD

Role: CONTACT

koudelka.adam@fnbrno.cz

+420 532 231 873

Ondrej Ludka, Prof.

Role: CONTACT

ludka.ondrej@fnbrno.cz

+420 532 231 976

Facility Contacts

Ondrej Ludka, Prof.

Role: primary

ludka.ondrej@fnbrno.cz

+420 532 231 976

Adam Koudelka, MD

Role: backup

koudelka.adam@fnbrno.cz

+420 532 231 873

Other Identifiers

POCUS-HF-FNBrno

Identifier Type: -

Identifier Source: org_study_id