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

NCT05411263 | Terminated

• 1 other identifier: EC-2021-268
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Portal Vein Pulsatility Index (PVPI)

  PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

Secondary Outcomes (7)

• Time integral of kinetic energy during the cardiac cycle

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

• Inferior vena cava diameter

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

• Inferior vena cava diameter respiratory variation

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

• Hepatic vein Pulsed wave Doppler signal

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

• Renal vein Pulsed wave Doppler signal

  Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

Study Arms (1)

Patients with advanced heart failure undergoing clinically indicated right heart catheterisation

EXPERIMENTAL

Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction.

Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

Interventions

Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino) DIAGNOSTIC_TEST

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.

Patients with advanced heart failure undergoing clinically indicated right heart catheterisation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• HeartKinetics: collaborator

Study Sites (1)

University Hospital Brussels

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Frederik H Verbrugge, MD; PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor/Head of Clinic

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 9, 2022
• Study Start: October 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year after completion of the study

Locations

BE (1)