Health TrialsbyHealthPanel

Point-of-Care Ultrasound in Chronic Heart Failure

ConditionCardiovascular Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HF focused POCUS

    Procedure/Surgery

    * 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 (in control arm)

    Procedure/Surgery

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

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Standard care armActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

The number of all AHF hospitalizations

The total number of all AHF hospitalizations

Time frame
12 months
2

The number of other unplanned hospitalizations

The total number of other unplanned hospitalizations

Time frame
12 months
3

The number of all unscheduled visits for any cause

The total number of all unscheduled visits for any cause

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masaryk University

Lead sponsor

Brno University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: