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

Primary Purpose

Congestion, Heart Failure, Right Heart Catheterisation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestion focused on measuring Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital BrusselsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with advanced heart failure undergoing clinically indicated right heart catheterisation

Arm Description

Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction.

Outcomes

Primary Outcome Measures

Portal Vein Pulsatility Index (PVPI)
PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal

Secondary Outcome Measures

Time integral of kinetic energy during the cardiac cycle
Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium).
Inferior vena cava diameter
Inferior vena cava diameter [mm] upon end-expiration
Inferior vena cava diameter respiratory variation
Inferior vena cava diameter respiratory variation [%]
Hepatic vein Pulsed wave Doppler signal
Categorical classification: Systolic wave > Diastolic wave Diastolic wave > Systolic wave Systolic flow reversal
Renal vein Pulsed wave Doppler signal
Categorical classification: Monophasic flow Discontinuous biphasic flow Discontinuous monophasic flow
Right ventricular (RV) free wall strain
Right ventricular (RV) free wall strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).
Right atrial strain
Right atrial strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).

Full Information

First Posted
May 31, 2022
Last Updated
September 17, 2023
Sponsor
Vrije Universiteit Brussel
Collaborators
HeartKinetics
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1. Study Identification

Unique Protocol Identification Number
NCT05411263
Brief Title
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)
Acronym
PORTAL
Official Title
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
HeartKinetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestion, Heart Failure, Right Heart Catheterisation, Central Venous Pressure, Doppler Echocardiography
Keywords
Congestion, Doppler echocardiography, Central venous pressure, Right heart catheterisation, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with advanced heart failure undergoing clinically indicated right heart catheterisation
Arm Type
Experimental
Arm Description
Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction.
Intervention Type
Diagnostic Test
Intervention Name(s)
Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino)
Intervention Description
As per inclusion criteria, all patients undergo right heart catheterisation to obtain a full profile of invasive hemodynamic measurements, including pulmonary arterial wedge pressure (PAWP), pulmonary artery pressure, right ventricular pressure, right atrial pressure (RAP), superior and/or inferior vena cava pressure, hepatic vein pressure with/without balloon occlusion. Immediately after the invasive hemodynamic exam, a comprehensive 2D, Color Doppler and Doppler echocardiography exam, including a Doppler study of the Vv. hepaticae, V. portae and V. renalis is performed. Based upon logistic feasibility, ballistocardiography and seismocardiography with the completely non-invasive Kino device (HeartKinetics, Waterloo, Belgium) is performed in a subpopulation of patients envisioned to be at least 50 patients.
Primary Outcome Measure Information:
Title
Portal Vein Pulsatility Index (PVPI)
Description
PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Secondary Outcome Measure Information:
Title
Time integral of kinetic energy during the cardiac cycle
Description
Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium).
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Inferior vena cava diameter
Description
Inferior vena cava diameter [mm] upon end-expiration
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Inferior vena cava diameter respiratory variation
Description
Inferior vena cava diameter respiratory variation [%]
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Hepatic vein Pulsed wave Doppler signal
Description
Categorical classification: Systolic wave > Diastolic wave Diastolic wave > Systolic wave Systolic flow reversal
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Renal vein Pulsed wave Doppler signal
Description
Categorical classification: Monophasic flow Discontinuous biphasic flow Discontinuous monophasic flow
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Right ventricular (RV) free wall strain
Description
Right ventricular (RV) free wall strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
Title
Right atrial strain
Description
Right atrial strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States).
Time Frame
Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Vanhentenrijk, MD; PharmD
Phone
+32 2 474 9060
Email
simon.vanhentenrijk@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik H Verbrugge, MD; PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Brussels
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Lemoine, RN
Phone
+32 2 474 9060
Email
ingrid.lemoine@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Frederik H Verbrugge, MD; PhD
First Name & Middle Initial & Last Name & Degree
Simon Vanhentenrijk, MD; PharmD
First Name & Middle Initial & Last Name & Degree
Theodoros Kalpakos, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data related will be made available upon reasonable request in adherence with transparency conventions in medical research, always through requests addressed to the primary investigator.
IPD Sharing Time Frame
1 year after completion of the study

Learn more about this trial

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

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