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

Recruiting

• Conditions: Heart Failure
• Interventions: Device: Assess Non-invasive filling pressure(NIFP) in heart failure patients

• Registration Number: NCT06593223
• Lead Sponsor: The University of Hong Kong-Shenzhen Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• 1.Patients under 18 years old 2.Patients with congenital heart diseases (e.g., tetralogy of Fallot, atrial septal defect, Fontan disease, single chamber disease) 3.Patients with implanted artificial mechanical valves, pacemaker or ICD. 4.Patients with significant back issues that prevent them from lying supine on the bed 5.Pregnant patients 6.Patient wight under 35 kg or over 150 kg 7.Patients who are attaching to other medical device that prevent them to receive a test by the study device.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute heart failure (AHF) patients	Assess Non-invasive filling pressure(NIFP) in heart failure 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	Assess Non-invasive filling pressure(NIFP) in 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.

Primary Outcome Measures

Name	Time	Method
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.	2025-7-1	Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.

Trial Locations

Locations (1)

Mingya Liu; 🇨🇳 Shenzhen, Guangdong, China