Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Portal Vein Pulsatility Index (PVPI)
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Portal Vein Pulsatility Index (PVPI)
Time Frame: 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 Outcomes
- Time integral of kinetic energy during the cardiac cycle(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Inferior vena cava diameter(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- 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(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Renal vein Pulsed wave Doppler signal(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Right ventricular (RV) free wall strain(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Right atrial strain(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
Investigators
Frederik Hendrik Verbrugge, MD PhD MSc
Clinical Professor/Head of Clinic
Universitair Ziekenhuis Brussel
