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Clinical Trials/NCT05411263
NCT05411263TerminatedNot Applicable

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

Vrije Universiteit Brussel2 sites in 1 country61 target enrollmentStarted: October 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
61
Locations
2
Primary Endpoint
Portal Vein Pulsatility Index (PVPI)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Frederik Hendrik Verbrugge, MD PhD MSc

Clinical Professor/Head of Clinic

Universitair Ziekenhuis Brussel

Study Sites (2)

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