Evaluating portal vein flow variability to assess right-sided heart congestion
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
NA · Vrije Universiteit Brussel · NCT05411263
This study is testing a new imaging technique to see if it can better measure blood flow and pressure in the veins of heart failure patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel (other) |
| Locations | 1 site (Jette, Brussels) |
| Trial ID | NCT05411263 on ClinicalTrials.gov |
What this trial studies
This study assesses the accuracy of a comprehensive venous Doppler echography, focusing on the portal vein pulsatility index (PVPI), to quantify right-sided venous pressures measured invasively. It includes a substudy that correlates invasive and non-invasive hemodynamic measurements using the Kino-cardiograph device. The goal is to improve the understanding of hemodynamic congestion in heart failure patients through advanced imaging techniques.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for right heart catheterization due to heart failure.
Not a fit: Patients with significant anatomical variations of the portal veins or advanced liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of right-sided heart congestion, improving patient management in heart failure.
How similar studies have performed: While the approach of using Doppler echography is established, the specific application of PVPI in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jette, Brussels
- University Hospital Brussels — Jette, Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Frederik H Verbrugge, MD; PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Simon Vanhentenrijk, MD; PharmD
- Email: simon.vanhentenrijk@uzbrussel.be
- Phone: +32 2 474 9060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congestion, Heart Failure, Right Heart Catheterisation, Central Venous Pressure, Doppler Echocardiography, Doppler echocardiography, Central venous pressure, Right heart catheterisation