An interventional study of novel wearable device in Heart Failure, sponsored by China-Japan Friendship Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Screening
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 108 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps.
Device: novel wearable device
Patients receive a standard of care for heart failure without a wearable device.
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.
Rate of Hospital Readmissions for Heart Failure
Total hospitalizations for heart failure will be monitored via follow-up.
Time frame: Up to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Compliance Percentage of Patients
Patient adherence to daily measurement and transmission of sensor readings will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Subjects Included the Endpoint of Cardiovascular Mortality
Rate of cardiovascular mortality will be monitored via follow-up.
Time frame: Up to 6 months
Subjects Included the Endpoint of all-cause Mortality
Rate of all-cause mortality will be monitored via follow-up.
Time frame: Up to 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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China-Japan Friendship Hospital