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Not yet recruiting NCT06887179

Point-of-Care Ultrasound in Chronic Heart Failure

No phase Interventional Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HF focused POCUS, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of Point-of-Care Ultrasound in the Management of Chronic Heart Failure

Overview

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.

Interventions

  • 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. 1. Lungs: Assessment of B-lines in midclavicular and midaxillary zones. 2.
  • Procedure Standard Care (in control arm)
    Standard care assessment with NT-proBNP on every scheduled visit.

Primary outcome measures

  • The primary outcome [Time frame: 12 months]
Secondary outcome measures (11)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • University Hospital Brno — Brno

Identifiers

NCT: NCT06887179 · POCUS-HF-FNBrno

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗