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

Not Applicable

Recruiting

• Conditions: Congestion; Central Venous Pressure; Doppler Echocardiography; Right Heart Catheterisation; Heart Failure
• Interventions: Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

• Registration Number: NCT05411263
• Lead Sponsor: Vrije Universiteit Brussel

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with advanced heart failure undergoing clinically indicated right heart catheterisation	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.

Primary Outcome Measures

Name	Time	Method
Portal Vein Pulsatility Index (PVPI)	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

Secondary Outcome Measures

Name	Time	Method
Time integral of kinetic energy during the cardiac cycle	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).
Inferior vena cava diameter	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam	Inferior vena cava diameter \[mm\] upon end-expiration
Inferior vena cava diameter respiratory variation	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam	Inferior vena cava diameter respiratory variation \[%\]
Hepatic vein Pulsed wave Doppler signal	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
Renal vein Pulsed wave Doppler signal	Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam	Categorical classification: * Monophasic flow; * Discontinuous biphasic flow; * Discontinuous monophasic flow
Right ventricular (RV) free wall strain	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).
Right atrial strain	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).

Trial Locations

Locations (1)

University Hospital Brussels; 🇧🇪 Jette, Brussels, Belgium