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

Study Overview
=================
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).

Official Title
-----------------
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study

Conditions
-----------------
Congestion, Heart Failure, Right Heart Catheterisation, Central Venous Pressure, Doppler Echocardiography

Intervention / Treatment
-----------------
* Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with advanced heart failure undergoing clinically indicated right heart catheterisation<br>Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction. | Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal Vein Pulsatility Index (PVPI) | PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time integral of kinetic energy during the cardiac cycle | Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium). | 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 | 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 [%] | 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 | 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 | 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). | 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). | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure