Decompensation, heart failure
Conditions
Interventions
Participants undergo the following measurements, outside of standard care:
- TTE and RF Sensing measurement.
- MRI and RF Sensing measurement.
- RF Sensing measurement during catheterization (only if
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients planned for a right heart catheterization with invasive pressure measurement • Patients that are screened for a left ventricular assist device or a heart transplant • Patients that have recently received a heart transplant • Patients with NYHA class II-IV heart failure, preserved as well as reduced ejection fraction • Patients with pulmonary hypertension • Patients with known (risk of) chemotherapy induced cardiac dysfunction • Patients with any cardiac arrhythmia • Patients with an implantable pulmonary artery pressure sensor •Cardiovascular patients on the intensive care unit or cardiac care unit undergoing daily hemodynamic measurements
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients that have an active implant (cardiac implant such as CRT, ICD, LVAD, or any other active implants such as insulin pump, cochlear implant or neural stimulator) that cannot be switched to passive or sensing mode. • Patients is expected to die within 6 months from any nonrelated disease • Patient that are not physically able to undergo TTE, MRI and/or RFS measurements at the time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint 1: correlation between RFS parameters and non-invasive hemodynamic parameters in cardiovascular patients. • Key parameters RFS: signal amplitude, area under the curve, average value, frequency, spectral content • Key parameters non-invasive hemodynamic measurements: estimated left ventricular end diastolic pressure, left ventricular ejection fraction, left ventricular stroke volume, right ventricular ejection fraction, right ventricular stroke volume | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint 1: correlation between RFS parameters and non-invasive hemodynamic parameters in cardiovascular patients. • Key parameters RFS: signal amplitude, area under the curve, average value, frequency, spectral content • Key parameters invasive hemodynamic measurements: atrial pressure, right ventricular pressure, pulmonary capillary wedge pressure and pulmonary artery pressure, diastolic/systolic/mean Secondary endpoint 2: Difference in RFS parameters in cardiovascular patients before and after treatment • Key parameters RFS: signal amplitude,area under the curve value, average value, frequency | — |
Countries
Netherlands
Contacts
Public ContactBR Steensma
Universitair Medisch Centrum Utrecht
Outcome results
None listed