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Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)

Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05411263
Acronym
PORTAL
Enrollment
61
Registered
2022-06-09
Start date
2021-10-01
Completion date
2024-06-30
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Pressure, Congestion, Doppler Echocardiography, Heart Failure, Right Heart Catheterisation

Keywords

Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure

Brief summary

This study evaluates the accuracy of a comprehensive venous Doppler echography including the portal vein pulsatility index (PVPI) to quantify invasively measured right-sided venous pressures. A substudy will correlate invasive and non-invasive hemodynamic measurements to ballistocardiography and seismocardiography with the Kino-cardiograph (Kino) device (HeartKinetics, Waterloo, Belgium).

Interventions

DIAGNOSTIC_TESTComprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

As per inclusion criteria, all patients undergo right heart catheterisation to obtain a full profile of invasive hemodynamic measurements, including pulmonary arterial wedge pressure (PAWP), pulmonary artery pressure, right ventricular pressure, right atrial pressure (RAP), superior and/or inferior vena cava pressure, hepatic vein pressure with/without balloon occlusion. Immediately after the invasive hemodynamic exam, a comprehensive 2D, Color Doppler and Doppler echocardiography exam, including a Doppler study of the Vv. hepaticae, V. portae and V. renalis is performed. Based upon logistic feasibility, ballistocardiography and seismocardiography with the completely non-invasive Kino device (HeartKinetics, Waterloo, Belgium) is performed in a subpopulation of patients envisioned to be at least 50 patients.

Sponsors

HeartKinetics
CollaboratorUNKNOWN
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* At least 18 year old and able to provide informed consent; * Consecutive patients scheduled for right heart catheterisation by a dedicated heart failure specialist at the Centre of Cardiovascular Diseases (University Hospital Brussels, Jette, Belgium).

Exclusion criteria

* Major anatomical variations of the portal veins (agenesis of left and right portal vein) and/or arterio-portal vein fistula; * Patients with Child-Pugh B or C liver cirrhosis or liver transplant; * Body Mass Index \< 20 kg/m².

Design outcomes

Primary

MeasureTime frameDescription
Portal Vein Pulsatility Index (PVPI)Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examPVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal

Secondary

MeasureTime frameDescription
Inferior vena cava diameterCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examInferior vena cava diameter \[mm\] upon end-expiration
Inferior vena cava diameter respiratory variationCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examInferior vena cava diameter respiratory variation \[%\]
Hepatic vein Pulsed wave Doppler signalCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examCategorical classification: * Systolic wave \> Diastolic wave * Diastolic wave \> Systolic wave * Systolic flow reversal
Time integral of kinetic energy during the cardiac cycleCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examMeasured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium).
Right ventricular (RV) free wall strainCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examRight ventricular (RV) free wall strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).
Right atrial strainCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examRight atrial strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).
Renal vein Pulsed wave Doppler signalCrosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography examCategorical classification: * Monophasic flow * Discontinuous biphasic flow * Discontinuous monophasic flow

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026