Clinical trial NCT06887179: Point-of-Care Ultrasound in Chronic Heart Failure
Official title: The Role of Point-of-Care Ultrasound in the Management of Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Heart failure
Diuretic therapy
Congestion
Point-of-Care Ultrasound
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: University Hospital Brno
First posted: 2025-03-20
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome
timeFrame: 12 months
Secondary outcomes:
measure: The number of all AHF hospitalizations
timeFrame: 12 months
measure: The number of other unplanned hospitalizations
timeFrame: 12 months
measure: The number of all unscheduled visits for any cause
timeFrame: 12 months
measure: The number of extra visits beyond the protocol schedule for HF treatment
timeFrame: 12 months
measure: The change in NT-proBNP
timeFrame: 12 months
measure: The change in eGFR
timeFrame: 12 months
measure: The change in Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 months
measure: The number of performed chest X-rays
timeFrame: 12 months
measure: The number of drainage procedures for fluidothorax or ascites.
timeFrame: 12 months
measure: Safety outcome
timeFrame: 12 months
measure: The level of hypokalemia <3.5 mmol/L
timeFrame: 12 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno
name: Ondrej Ludka, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Brno
name: Ondrej Ludka, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital Brno
name: Adam Koudelka, MD
role: PRINCIPAL_INVESTIGATOR
References: