Point-of-Care Ultrasound in Chronic Heart Failure (POCUS-HF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Procedure: HF focused POCUS; Procedure: Standard Care (in control arm)

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Koudelka, MD; Phone Number: +420 532 231 873; Email: koudelka.adam@fnbrno.cz
• Study Contact Backup: Name: Ondrej Ludka, Prof.; Phone Number: +420 532 231 976; Email: ludka.ondrej@fnbrno.cz

Study Locations

• Czech Republic
  • Brno, Czech Republic, 625 00
    • University Hospital Brno
    • Contact: Adam Koudelka, MD; Phone Number: +420 532 231 873; Email: koudelka.adam@fnbrno.cz
    • Contact: Ondrej Ludka, Prof.; Phone Number: +420 532 231 976; Email: ludka.ondrej@fnbrno.cz
    • Contact: Adam Koudelka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 visitblood count, urea, creatinine, glycaemia and electrolytes on every visit; HF focused POCUS on every visit	Procedure: 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.Lungs: Assessment of B-lines in midclavicular and midaxillary zones.Pleural EffusionInferior Vena CavaAscites
Active Comparator: 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 visitblood count, urea, creatinine, glycaemia and electrolytes on every visit	Procedure: Standard Care (in control arm); Standard care assessment with NT-proBNP on every scheduled visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of all AHF hospitalizations	The total number of all AHF hospitalizations	12 months
The number of other unplanned hospitalizations	The total number of other unplanned hospitalizations	12 months
The number of all unscheduled visits for any cause	The total number of all unscheduled visits for any cause	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	12 months
The change in NT-proBNP	The change in NT-proBNP (ng/l)	12 months
The change in eGFR	The change in eGFR (ml/s/1,73m2)	12 months
The number of performed chest X-rays	The total number of performed chest X-rays	12 months
The number of drainage procedures for fluidothorax or ascites.	The total number of drainage procedures for fluidothorax or ascites.	12 months
The level of hypokalemia <3.5 mmol/L	The number of patients having hypokalemia <3.5 mmol/L	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.	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).	12 months

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: University Hospital Brno
• Investigators: Study Chair: Ondrej Ludka, Prof., University Hospital Brno; Study Director: Ondrej Ludka, Prof., University Hospital Brno; Principal Investigator: Adam Koudelka, MD, University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Congestion; Point-of-Care Ultrasound; Diuretic therapy
• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases
• Other Study ID Numbers: POCUS-HF-FNBrno

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No