Heart FailureNCT06593223
Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
An observational study of Heart Failure, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial 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 , , . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Assess Non-invasive filling pressure(NIFP) in heart failure patients
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Acute heart failure；Stabilized outpatient chronic heart failure patients；Willing to sign the inform consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mingya Liu
Shenzhen, Guangdong, 518000
Quan Yang, +8618201008996, yangq9@hku-szh.org
Wenqi Li, +8618575557007, liwq7@hku-szh.org
About this study
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
- Heart Failure
- Being tested
- Assess Non-invasive filling pressure(NIFP) in heart failure patients
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess Non-invasive filling pressure(NIFP) in heart failure patientsDevice
Assess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward
| Study group | Role | What they receive |
|---|---|---|
| Acute heart failure (AHF) patients | For acute heart failure (AHF) patients：NIFP test were conducted 2-3 times during the hospital stay. The first test is supposed to be conducted close to the time of admission. In the same day of each NIFP test a physical examination is performed to the patient and clinical congestion score (CCS) is recorded. If available, the Nt-proBNP test result in the same day of NIFP test is recorded. Echocardiography examination is scheduled for most of patients and Ejection Fraction (EF), E/A, and E/e' ratio are recorded as well. Receives: Device: Assess Non-invasive filling pressure(NIFP) in heart failure patients | |
| Stabilized outpatient chronic heart failure patients | For stabilized outpatient chronic heart failure patients：NIFP test was conducted and if Nt-proBNP test result is available in the same day it will be recorded as well. Receives: Device: Assess Non-invasive filling pressure(NIFP) in heart failure patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2025-7-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Fiber Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593223
- Sponsor's protocol ID
- 伦[2019]165
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06593223
- Acronym / sponsor ID
- 伦[2019]165
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Fiber Medical Technology Co., Ltd.
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure (AHF) patients | – | Device: Assess Non-invasive filling pressure(NIFP) in heart failure patientsFor acute heart failure (AHF) patients：NIFP test were conducted 2-3 times during the hospital stay. The first test is supposed to be conducted close to the time of admission. In the same day of each NIFP test a physical examination is performed to the patient and clinical congestion score (CCS) is recorded. If available, the Nt-proBNP test result in the same day of NIFP test is recorded. Echocardiography examination is scheduled for most of patients and Ejection Fraction (EF), E/A, and E/e' ratio are recorded as well. |
| Stabilized outpatient chronic heart failure patients | – | Device: Assess Non-invasive filling pressure(NIFP) in heart failure patientsFor stabilized outpatient chronic heart failure patients：NIFP test was conducted and if Nt-proBNP test result is available in the same day it will be recorded as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- Acute heart failure；Stabilized outpatient chronic heart failure patients；Willing to sign the inform consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess Non-invasive filling pressure(NIFP) in heart failure patientsAssess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward | Device | Acute heart failure (AHF) patients, Stabilized outpatient chronic heart failure patients |
Primary outcome
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
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.