This study aims to evaluate A-mode ultrasound for assessing JVPW characteristics as a non-invasive tool to discriminate between healthy subjects and those with pulmonary arterial hypertension patients, and to assess if JVPW changes relate to changes…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
Pulmonale arteriële hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The full sonographic JVPW at rest will be compared between patients and healthy
controls. Invasive measurement of right ventricular end-diastolic pressure
(RVEDP) through RHC will be analyzed to determine whether RVEDP can be
predicted using JVPW characteristics.
Secondary outcome
JVPW assessments in patients after intravenous saline. Invasive hemodynamic
parameters using RHC.
Background summary
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by
high mortality and significant complications, particularly right ventricular
(RV) failure characterized by diastolic dysfunction and elevated ventricular
filling pressures. Traditional assessment through right heart catheterization
(RHC) is invasive and has other limitations, prompting a need for non-invasive
risk stratification methods. This study proposes sonographic assessment of the
jugular venous pulse wave (JVPW) as non-invasive alternative, leveraging the
internal jugular vein as an indicator of right atrial pressure. Prior research
indicates correlations between jugular vein metrics and hemodynamic parameters,
but no studies have yet linked JVPW to invasive measures in PAH patients. The
study hypothesizes that JVPW characteristics will differ between suspected PH
patients and healthy controls and that JVPW characteristics respond to (changes
in) invasive cardiopulmonary hemodynamics, specifically RV filling pressures.
Study objective
This study aims to evaluate A-mode ultrasound for assessing JVPW
characteristics as a non-invasive tool to discriminate between healthy subjects
and those with pulmonary arterial hypertension patients, and to assess if JVPW
changes relate to changes in RV filling pressures in response to intravenous
saline.
Study design
This open-label, cross-sectional observational study with a single-arm
intervention will compare patients with suspected PH (all world health
organization (WHO) groups) (n=15) to age- and sex-matched healthy controls
(n=15). Participants will be recruited through referrals and snowball sampling.
Patients will receive right heart catheterization as part of routine clinical
care, during which they will undergo A-mode sonographic measurements of the
JVPW at rest, and after IV saline infusion to mimic worsening PAH. Invasive
hemodynamic data will be recorded during both JVPW assessments. Controls will
only receive A-mode sonographic JVPW measurements.
Study burden and risks
Participation in this study poses very low additional risk for the patient
group, as the RHC is part of standard clinical care. The control group faces
negligible risk, as they will only undergo non-invasive assessment; overall,
both groups are well-protected through established clinical protocols and
careful participant selection.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age 18 years or older
- Referred for RHC without vasoreactivity assessment (i.e., RHC without Flolan
procedure) at Radboudumc, due to suspected pulmonary hypertension (all world
health organization (WHO) groups)
- Able to perform the informed consent procedure
Exclusion criteria
A subject who meets any of the following criteria will be excluded from
participation in this study:
- Any contraindication for IV saline (i.e., decompensated heart failure; severe
peripheral oedema; severe liver disease; hypernatremia; renal function of
eGFR<30)
- Unable to receive ultrasound assessment of the right IJV (i.e.,
significant/untreated neck wounds or other dermatological conditions)
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87880.091.24 |