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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Doppler Echocardiography; Congestion; Right Heart Catheterisation; Central Venous Pressure
• Intervention / Treatment: Diagnostic test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Vanhentenrijk, MD; PharmD; Phone Number: +32 2 474 9060; Email: simon.vanhentenrijk@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Recruiting
      • University Hospital Brussels
      • Contact: Ingrid Lemoine, RN; Phone Number: +32 2 474 9060; Email: ingrid.lemoine@uzbrussel.be
      • Principal Investigator: Frederik H Verbrugge, MD; PhD
      • Sub-Investigator: Simon Vanhentenrijk, MD; PharmD
      • Sub-Investigator: Theodoros Kalpakos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with advanced heart failure undergoing clinically indicated right heart catheterisation; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time integral of kinetic energy during the cardiac cycle	Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium).	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Inferior vena cava diameter	Inferior vena cava diameter [mm] upon end-expiration	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Inferior vena cava diameter respiratory variation	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	Categorical classification: Systolic wave > Diastolic wave; Diastolic wave > Systolic wave; Systolic flow reversal	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Renal vein Pulsed wave Doppler signal	Categorical classification: Monophasic flow; Discontinuous biphasic flow; Discontinuous monophasic flow	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Right ventricular (RV) free wall strain	Right ventricular (RV) free wall strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Right atrial strain	Right atrial strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: HeartKinetics
• Investigators: Principal Investigator: Frederik H Verbrugge, MD; PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 4, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Congestion; Doppler echocardiography; Central venous pressure; Right heart catheterisation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EC-2021-268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data related will be made available upon reasonable request in adherence with transparency conventions in medical research, always through requests addressed to the primary investigator.
• IPD Sharing Time Frame: 1 year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No