Clinical trial NCT05411263: Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)
Official title: Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congestion
Heart Failure
Right Heart Catheterisation
Central Venous Pressure
Doppler Echocardiography
Keywords: Congestion
Doppler echocardiography
Central venous pressure
Right heart catheterisation
Heart Failure
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: HeartKinetics
First posted: 2022-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
measure: Portal Vein Pulsatility Index (PVPI)
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Secondary outcomes:
measure: Time integral of kinetic energy during the cardiac cycle
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Inferior vena cava diameter
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Inferior vena cava diameter respiratory variation
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Hepatic vein Pulsed wave Doppler signal
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Renal vein Pulsed wave Doppler signal
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Right ventricular (RV) free wall strain
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
measure: Right atrial strain
timeFrame: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: University Hospital Brussels
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Frederik H Verbrugge, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: