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

NCT06593223 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • Shenzhen Fiber Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • The University of Hong Kong-Shenzhen Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593223 on ClinicalTrials.gov