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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Acute heart failure;Stabilized outpatient chronic heart failure patients;Willing to sign the inform consent

Locations
Other Locations
China
Mingya Liu
RECRUITING
Shenzhen
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 400
Treatments
Acute heart failure (AHF) patients
For acute heart failure (AHF) patients:NIFP test were conducted 2-3 times during the hospital stay. The first test is supposed to be conducted close to the time of admission. In the same day of each NIFP test a physical examination is performed to the patient and clinical congestion score (CCS) is recorded. If available, the Nt-proBNP test result in the same day of NIFP test is recorded. Echocardiography examination is scheduled for most of patients and Ejection Fraction (EF), E/A, and E/e' ratio are recorded as well.
Stabilized outpatient chronic heart failure patients
For stabilized outpatient chronic heart failure patients:NIFP test was conducted and if Nt-proBNP test result is available in the same day it will be recorded as well.
Related Therapeutic Areas
Sponsors
Collaborators: Shenzhen Fiber Medical Technology Co., Ltd.
Leads: The University of Hong Kong-Shenzhen Hospital

This content was sourced from clinicaltrials.gov