Actively Recruiting

Age: 18Years +
All Genders
NCT06593223

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

Led by The University of Hong Kong-Shenzhen Hospital · Updated on 2024-09-19

400

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong-Shenzhen Hospital

Lead Sponsor

S

Shenzhen Fiber Medical Technology Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute heart failure
  • Stabilized outpatient chronic heart failure patients
  • Willing to sign the informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Congenital heart diseases such as tetralogy of Fallot, atrial septal defect, Fontan disease, or single chamber disease
  • Implanted artificial mechanical valves, pacemaker, or ICD
  • Significant back issues preventing lying supine on the bed
  • Pregnant patients
  • Body weight under 35 kg or over 150 kg
  • Attached to other medical devices preventing use of study device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Mingya Liu

Shenzhen, Guangdong, China, 518000

Actively Recruiting

Loading map...

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here