Trials / Terminated
TerminatedNCT05411263
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Vrije Universiteit Brussel · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
- First posted
- 2022-06-09
- Last updated
- 2025-07-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05411263. Inclusion in this directory is not an endorsement.