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

NCT ID: NCT06593223

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-07-01

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Assess Non-invasive filling pressure(NIFP) in heart failure patients

Intervention Type: DEVICE

Assess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward

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.

Assess Non-invasive filling pressure(NIFP) in heart failure patients

Intervention Type: DEVICE

Assess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward

Interventions

Assess Non-invasive filling pressure(NIFP) in heart failure patients

Assess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Fiber Medical Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong-Shenzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mingya Liu

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Quan Yang

Role: primary

yangq9@hku-szh.org

+8618201008996

Wenqi Li

Role: backup

liwq7@hku-szh.org

+8618575557007

Other Identifiers

伦[2019]165

Identifier Type: -

Identifier Source: org_study_id