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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Hong Kong-Shenzhen Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patient visits to hospital with suspected heart failure (HF) or with history of HF were enrolled. Some of the patients were admitted to cardiology ward due to initial diagnosis of acute heart failure (AHF). Some of the patients are who make a planned visit to outpatient clinic with history of HF. All patients are over 18 years old and are willing to sign the inform consent.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

    Device

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Acute heart failure (AHF) patients1 intervention
Group B: Stabilized outpatient chronic heart failure patients1 intervention

Trial outcomes

Primary outcomes

1

Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.

Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.

Time frame
2025-7-1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong-Shenzhen Hospital

Lead sponsor

Shenzhen Fiber Medical Technology Co., Ltd.

Collaborator