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

NCT05411263 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-07-03

No results posted yet for this study

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. 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

Interventions

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.

Sponsors & Collaborators

  • HeartKinetics

    collaborator UNKNOWN

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • Frederik H Verbrugge, MD; PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05411263 on ClinicalTrials.gov