Novel Wearable Device for Heart Failure Management

Not Applicable

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Device: novel wearable device

• Registration Number: NCT05642650
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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. 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 Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-08
• Status Verified: 2023-02
• Study Start: 2023-02-07
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Diagnosis of HF ≥ 3 months
2. Diagnosis of NYHA Class III HF
3. Subjects with age ≥ 18 years
4. At least 1 HF hospitalization within 12 months prior to enrollment
5. Subjects with elevated ambulatory levels of BNP/NT-proBNP

Exclusion Criteria

1. Subjects unable to cooperate to complete the trial.
2. Subjects with severe arrhythmia.
3. Subjects with cardiac shock.
4. Subjects with acute myocardial infarction.
5. Subjects with local skin infections and injuries in the jugular vein area
6. Subjects with active uncontrolled infections
7. Subjects with eGFR < 25 mL/min/1.73m2
8. Pregnant women, or women likely to undergo pregnancy
9. Subjects with life expectancy less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel wearable device strategy group	novel 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.

Primary Outcome Measures

Name	Time	Method
Rate of Hospital Readmissions for Heart Failure	Up to 6 months	Total hospitalizations for heart failure will be monitored via follow-up.

Secondary Outcome Measures

Name	Time	Method
Compliance Percentage of Patients	Up to 6 months	Patient adherence to daily measurement and transmission of sensor readings will be recorded.
Freedom From a Device/System-related Complication	Up to 6 months	Device/System-related Complications refer to adverse events such as device failure and allergy.
Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)	Up to 6 months	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.
Concordance of the Jugular Vein Pressure with the RHC Measurement	Up to 6 months	Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization.
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.	Up to 6 months	Change from baseline to 6 months in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions.
Change in Quality of Life	Up to 6 months	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.
Change in New York Heart Association (NYHA) functional class.	Up to 6 months	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.