Radio-frequency sensing: non-invasive monitoring of heart failure progressio

Recruiting

Conditions: decompensation
Heart failure
10019280

Registration Number: NL-OMON56751

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint 1: correlation between RFS parameters and non-invasive<br /><br>hemodynamic parameters in cardiovascular patients.<br /><br>• Key parameters RFS: signal amplitude, area under the curve, average value,<br /><br>frequency, spectral content<br /><br>• Key parameters non-invasive hemodynamic measurements: estimated left<br /><br>ventricular end diastolic pressure, left ventricular ejection fraction, left<br /><br>ventricular stroke volume, right ventricular ejection fraction, right<br /><br>ventricular stroke volume </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint 1: correlation between RFS parameters and non-invasive<br /><br>hemodynamic parameters in cardiovascular patients.<br /><br>• Key parameters RFS: signal amplitude, area under the curve, average value,<br /><br>frequency, spectral content<br /><br>• Key parameters invasive hemodynamic measurements: atrial pressure, right<br /><br>ventricular pressure, pulmonary capillary wedge pressure and pulmonary artery<br /><br>pressure, diastolic/systolic/mean<br /><br><br /><br>Secondary endpoint 2: Difference in RFS parameters in cardiovascular patients<br /><br>before and after treatment<br /><br>• Key parameters RFS: signal amplitude,area under the curve value, average<br /><br>value, frequency</p><br>