Using a non-invasive device to assess congestion in heart failure patients
Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
This study is testing a new non-invasive device to see if it can more accurately check for congestion in people with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong-Shenzhen Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT06593223 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of a novel non-invasive filling pressure (NIFP) device that assesses congestion in patients with heart failure. Congestion is a critical factor in heart failure management, and current assessment methods can be unreliable. The study will involve serial assessments of congestion using the NIFP device, which could provide a more accurate and efficient alternative to traditional methods like physical exams and BNP tests. Participants will include both acute heart failure patients and stabilized outpatient chronic heart failure patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with acute heart failure or stabilized chronic heart failure who can provide informed consent.
Not a fit: Patients under 18 years old, those with congenital heart diseases, or individuals with certain medical devices or conditions that prevent participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to more accurate and timely assessments of congestion in heart failure patients, improving their management and outcomes.
How similar studies have performed: While there is ongoing research in non-invasive assessment methods for heart failure, this specific approach using the NIFP device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenzhen, Guangdong
- Mingya Liu — Shenzhen, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.