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

Heart Failure Clinical Trial

— PORTAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411263
• Other study ID #: EC-2021-268
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Vrije Universiteit Brussel
• Contact: Simon Vanhentenrijk, MD; PharmD
• Phone: +32 2 474 9060
• Email: simon.vanhentenrijk[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Pressure
• Congestion
• Doppler Echocardiography
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Brussels	Jette	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	HeartKinetics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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