NCT06593223 Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
| NCT ID | NCT06593223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong-Shenzhen Hospital |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-07-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT06593223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06593223 currently recruiting?
Yes, NCT06593223 is actively recruiting participants. Visit ClinicalTrials.gov or contact The University of Hong Kong-Shenzhen Hospital to inquire about joining.
Where is the NCT06593223 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT06593223 clinical trial?
NCT06593223 is sponsored by The University of Hong Kong-Shenzhen Hospital. The trial plans to enroll 400 participants.
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