Pulmonary Hypertension High blood pressure in the arteries of the lungs
Conditions
Interventions
Non-invasive arterial pressure waveforms are measured in patients suspected of pulmonary hypertension undergoing RHC treatment in the cardiac catheterization lab. Because the study specifically focuse
The data collection consists of two phases.Phase 1 involves obtaining 10 minutes of good waveform data in supine position and 10 minutes of good waveform data in sitting position using the ClearSight/
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: = 18 years of ageInformed consentPlanned rightsided heart catherisation for suspected of diagnosed pulmonary hypertensionAwake and sponteneously breathing and in the absence of anaesthesia
Exclusion criteria
Exclusion criteria: Inability to measure non-invasive finger blood pressure according to the instructions of the CS/EV1000/HemoSphere system's manualPatients with tricuspid stenosis or that have undergone the placement of a tricuspid valve clip (TriClip)Female patients with known pregnancyPatients with dialysis shuntPatients with severe intracardiac shunt or a congenital heart defectPatients with history of heart transplant, cardiac valve repair or valve replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to assess whether the non-invasive arterial pressure waveform, measured at finger level, shows distinctive morphological features that can be used in the early detection of PH. The performance of the model is evaluated based on predictive accuracy, using the following parameters: sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and the area under the receiver operating characteristic curve (AUC). | — |
Secondary
| Measure | Time frame |
|---|---|
| The influence of additional parameters on model performance will be assessed. In addition, model performance for different subgroups of the patient population will be determined (biological sex, severity of PH underlying cause, positioning, e.g. supine or upright). | — |
Countries
Netherlands
Contacts
Public ContactY.K. Lam
Amsterdam UMC
Outcome results
None listed