CongestionPORTALNCT05411263
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)
A study testing Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino) in people with Congestion and Heart Failure, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Congestion, Heart Failure, Right Heart Catheterisation
- What is being tested?
- Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Congestion, Heart Failure, Right Heart Catheterisation, Central Venous Pressure, Doppler Echocardiography
- Being tested
- Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)
- Keywords
- Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal Vein Pulsatility Index (PVPI)
PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal
Measured: 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
Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium).
Measured: 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
Measured: 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 [%]
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Oct 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- HeartKinetics
- Responsible party
- Principal investigator, Frederik Hendrik Verbrugge, MD PhD MSc, Universitair Ziekenhuis Brussel
- Investigators
- Frederik H Verbrugge, MD; PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411263
- Sponsor's protocol ID
- EC-2021-268
- Acronym
- PORTAL
- Status last verified
- Jun 2025
- First submitted
- 31 May 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
- ClinicalTrials.gov ID
- NCT05411263
- Acronym / sponsor ID
- PORTAL / EC-2021-268
- Conditions
- Congestion, Heart Failure, Right Heart Catheterisation, Central Venous Pressure, Doppler Echocardiography
- Keywords
- Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- HeartKinetics
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced heart failure undergoing clinically indicated right heart catheterisation | Experimental | Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patients with advanced heart failure undergoing clinically indicated right heart catheterisation |
Primary outcome
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
7 secondary outcomes
Time integral of kinetic energy during the cardiac cycle
Time frame: 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 respiratory variation
Time frame: 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
Renal vein Pulsed wave Doppler signal
Time frame: 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 atrial strain
Time frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik H Verbrugge, MD; PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino) in people with Congestion and Heart Failure, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal Vein Pulsatility Index (PVPI) (time frame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.