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

V

Vrije Universiteit Brussel

Status

Terminated

Conditions

Doppler Echocardiography
Right Heart Catheterisation
Heart Failure
Congestion
Central Venous Pressure

Treatments

Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

Study type

Interventional

Funder types

Other

Identifiers

NCT05411263
EC-2021-268

Details and patient eligibility

About

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).

Enrollment

61 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

Patients with advanced heart failure undergoing clinically indicated right heart catheterisation
Experimental group
Description:
Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction.
Treatment:
Diagnostic Test: Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Simon Vanhentenrijk, MD; PharmD

Data sourced from clinicaltrials.gov

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