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

June 30, 2025 updated by: Frederik Hendrik Verbrugge, MD PhD MSc, Vrije Universiteit Brussel

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • University Hospital Brussels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Portal Vein Pulsatility Index (PVPI)
Time Frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time integral of kinetic energy during the cardiac cycle
Time Frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
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
Time Frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
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
Time Frame: 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
Time Frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HeartKinetics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frederik H Verbrugge, MD; PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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