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Poor recruitment
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| Name | Class |
|---|---|
| HeartKinetics | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced heart failure undergoing clinically indicated right heart catheterisation | Experimental | Patients with advanced heart failure undergoing right heart catheterisation as clinically indicated, irrespectively of their ejection fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive transthoracic echocardiography, Doppler echography & Kino-cardiograph (Kino) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Portal Vein Pulsatility Index (PVPI) | PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Measure | Description | Time Frame |
|---|---|---|
| Time integral of kinetic energy during the cardiac cycle | Measured by a combination of ballistocardiography and seismocardiography with the Kino device (HeartKinetics, Waterloo, Belgium). | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Inferior vena cava diameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik H Verbrugge, MD; PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brussels | Jette | Brussels Capital | 1090 | Belgium |
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.
1 year after completion of the study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2022 | May 30, 2022 |
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|
Inferior vena cava diameter [mm] upon end-expiration |
| Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Inferior vena cava diameter respiratory variation | 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 | Categorical classification:
| Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Renal vein Pulsed wave Doppler signal | Categorical classification:
| Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| 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). | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Right atrial strain | Right atrial strain assessed in the RV focused view offline with EchoPAC (General Electric Healthcare, Chicago, IL, United States). | Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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