Congestive Heart Failure Clinical Trial
Official title:
Hemodynamic Assessment Throughout Diuretic Treatment in Acute Decompensated Heart Failure
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.
This study will assess the ability of a novel optical measurement system to determine changes
in the hemodynamic status of heart failure patients admitted to the hospital with a primary
diagnosis of acute decompensated heart failure. Patients will be measured with both the novel
measurement system and reference devices that are FDA-cleared for hemodynamic measurements.
The measurements from the novel system will be compared to reference variables describing
hemodynamic and congestive status, including stroke volume, central venous pressure, and
serum levels of NT-proBNP.
All patients enrolled in the study will first provide written informed consent to participate
and then the research coordinator will check that the subject meets all study inclusion
criteria and does not meet any of the study exclusion criteria. Enrolled subjects will
undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over
the course of their hospitalization. There will be at least eight (8) hours between
assessment sessions.
Each assessment session includes recording of the subject's weight, measurements with the
reference devices, and measurements with the novel optical system. During the session, the
subject will be assessed in the supine, sitting, and standing positions. NT-proBNP
measurements will be done at the start of study participation and the end. A market research
questionnaire will be administered to the subject following the first measurement session.
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