Heart FailureNCT05642650
Novel Wearable Device for Heart Failure Management
A study testing novel wearable device in people with Heart Failure, run by China-Japan Friendship Hospital.
Trial summary
Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. 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?
- novel wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 7 Feb 2023to 30 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of HF ≥ 3 months
- Diagnosis of NYHA Class III HF
- Subjects with age ≥ 18 years
- At least 1 HF hospitalization within 12 months prior to enrollment
- Subjects with elevated ambulatory levels of BNP/NT-proBNP
Who cannot join
- Subjects unable to cooperate to complete the trial.
- Subjects with severe arrhythmia.
- Subjects with cardiac shock.
- Subjects with acute myocardial infarction.
- Subjects with local skin infections and injuries in the jugular vein area
- Subjects with active uncontrolled infections
Show all 9Show fewer
- Subjects with eGFR < 25 mL/min/1.73m2
- Pregnant women, or women likely to undergo pregnancy
- Subjects with life expectancy less than 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure
Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.
Read the detailed description
The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.
- Conditions
- Heart Failure
- Being tested
- novel wearable device
- Keywords
- Novel Wearable Device, remote monitoring, Right heart catheterization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel wearable deviceDevice
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Novel wearable device strategy group | Experimental | Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps. Receives: Device: novel wearable device |
| Control group | No intervention | Patients receive a standard of care for heart failure without a wearable device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hospital Readmissions for Heart Failure
Total hospitalizations for heart failure will be monitored via follow-up.
Measured: Up to 6 months
Secondary outcomes (7)
Concordance of the Jugular Vein Pressure with the RHC Measurement
Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization.
Measured: Up to 6 months
Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
Change from baseline to 6 months in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain Natriuretic Peptide(BNP). NT-proBNP/BNP level will be measured using commercial kits system during the follow-up period. Change from baseline was defined as the value of NT-proBNP/BNP at 6 months minus the baseline value. Baseline value was defined as the mean of all available measurements from the screening visit.
Measured: Up to 6 months
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
Change from baseline to 6 months in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions.
Measured: Up to 6 months
Compliance Percentage of Patients
Patient adherence to daily measurement and transmission of sensor readings will be recorded.
Measured: Up to 6 months
Change in Quality of Life
Quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) answered by the patients directly on a patient application.KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Up to 6 months
Change in New York Heart Association (NYHA) functional class.
NYHA class will be evaluated according to the patients' clinical characteristics during the follow-up.NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity; Class I being best and Class IV being the worst functional class. Class I has no limitation to physical activity, Class II has slight limitation to physical activity, Class III has marked limitation of physical activity, and Class IV is unable to carry out any physical activity without severe discomfort.
Measured: Up to 6 months
Freedom From a Device/System-related Complication
Device/System-related Complications refer to adverse events such as device failure and allergy.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start7 Feb 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 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.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642650
- Sponsor's protocol ID
- 2022-NHLHCRF-YXHZ-01
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure
- ClinicalTrials.gov ID
- NCT05642650
- Acronym / sponsor ID
- 2022-NHLHCRF-YXHZ-01
- Conditions
- Heart Failure
- Keywords
- Novel Wearable Device, remote monitoring, Right heart catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 Dec 2022 (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.
Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.
Detailed description
The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel wearable device strategy group | Experimental | Device: novel wearable devicePatients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps. |
| Control group | No intervention | –Patients receive a standard of care for heart failure without a wearable device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of HF ≥ 3 months
- Diagnosis of NYHA Class III HF
- Subjects with age ≥ 18 years
- At least 1 HF hospitalization within 12 months prior to enrollment
- Subjects with elevated ambulatory levels of BNP/NT-proBNP
Key exclusion criteria (9 listed)
- Subjects unable to cooperate to complete the trial.
- Subjects with severe arrhythmia.
- Subjects with cardiac shock.
- Subjects with acute myocardial infarction.
- Subjects with local skin infections and injuries in the jugular vein area
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 |
|---|---|---|
| novel wearable devicePatients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge. | Device | Novel wearable device strategy group |
Primary outcome
Rate of Hospital Readmissions for Heart Failure
Time frame: Up to 6 months
Total hospitalizations for heart failure will be monitored via follow-up.
7 secondary outcomes
Concordance of the Jugular Vein Pressure with the RHC Measurement
Time frame: Up to 6 months
Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
Time frame: Up to 6 months
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
Time frame: Up to 6 months
Compliance Percentage of Patients
Time frame: Up to 6 months
Change in Quality of Life
Time frame: Up to 6 months
Change in New York Heart Association (NYHA) functional class.
Time frame: Up to 6 months
Freedom From a Device/System-related Complication
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing novel wearable device in people with Heart Failure, run by China-Japan Friendship Hospital.
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 5 inclusion and 9 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Di Sun, Dr. (010-84206809, sundi0929@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hospital Readmissions for Heart Failure (time frame: Up to 6 months). 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 8 Feb 2023.