Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)
NCT ID: NCT05411263
Last Updated: 2025-07-03
Study Results
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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TERMINATED
NA
61 participants
INTERVENTIONAL
2021-10-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with Child-Pugh B or C liver cirrhosis or liver transplant;
* Body Mass Index \< 20 kg/m².
18 Years
99 Years
ALL
No
Sponsors
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HeartKinetics
UNKNOWN
Vrije Universiteit Brussel
OTHER
Responsible Party
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Frederik Hendrik Verbrugge, MD PhD MSc
Clinical Professor/Head of Clinic
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
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EC-2021-268
Identifier Type: -
Identifier Source: org_study_id
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