Point-of-Care Ultrasound in Chronic Heart Failure

NCT06887179 | Not Yet Recruiting DMC

• 1 other identifier: POCUS-HF-FNBrno
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Heart failure; Diuretic therapy; Congestion; Point-of-Care Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The number of all AHF hospitalizations

  12 months

• The number of other unplanned hospitalizations

  12 months

• The number of all unscheduled visits for any cause

  12 months

• The number of extra visits beyond the protocol schedule for HF treatment

  12 months

• The change in NT-proBNP

  12 months

Study Arms (2)

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

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

Procedure: Standard Care (in control arm)

Interventions

HF focused POCUS 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

Intervention Arm

Standard Care (in control arm) PROCEDURE

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

Standard care arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaryk University: lead
• University Hospital Brno: collaborator

Study Sites (1)

University Hospital Brno

Brno, 625 00, Czechia

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ondrej Ludka, Prof.

  University Hospital Brno

  STUDY CHAIR

• Ondrej Ludka, Prof.

  University Hospital Brno

  STUDY DIRECTOR

• Adam Koudelka, MD

  University Hospital Brno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Koudelka, MD

CONTACT

+420 532 231 873; koudelka.adam@fnbrno.cz

Ondrej Ludka, Prof.

CONTACT

+420 532 231 976; ludka.ondrej@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)