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

NCT ID: NCT05411263

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Congestion Heart Failure Right Heart Catheterisation Central Venous Pressure Doppler Echocardiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartKinetics

UNKNOWN

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Frederik Hendrik Verbrugge, MD PhD MSc

Clinical Professor/Head of Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederik H Verbrugge, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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University Hospital Brussels

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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EC-2021-268

Identifier Type: -

Identifier Source: org_study_id

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