Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients

Congestion plays a key role in heart failure (HF) trajectory .Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures. Hemodynamic congestion refers to elevated cardiac filling pressures, which may occur days or weeks before the presentation of symptoms , , . Serial assessment of congestion is required in each encounter of the HF patients, while in current clinical practice, serial assessment of congestion relies on physical examination, sometimes supported by BNP test. Both physical and BNP test are reported to be unreliable in some cases ， . Echocardiography is good tool, but it requires skilled physician to operation and is more time consuming. In general, there is unmet needs of better tools for serial assessment of congestion in HF patient management. In this study, we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients.

NCT Number	NCT06593223
Lead Sponsor	The University of Hong Kong-Shenzhen Hospital Collaborators: Shenzhen Fiber Medical Technology Co., Ltd.
Conditions	Heart Failure
Enrollment	400 participants
Start Date	2022-07-01
Primary Completion	2025-07-01 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2024-09-19