Novel Wearable Device for Heart Failure Management

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: novel wearable device

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 Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Novel wearable device strategy group; 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 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.
NO_INTERVENTION: Control group; Patients receive a standard of care for heart failure without a wearable device.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 6 months
Compliance Percentage of Patients	Patient adherence to daily measurement and transmission of sensor readings will be recorded.	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.	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.	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.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Included the Endpoint of Cardiovascular Mortality	Rate of cardiovascular mortality will be monitored via follow-up.	Up to 6 months
Subjects Included the Endpoint of all-cause Mortality	Rate of all-cause mortality will be monitored via follow-up.	Up to 6 months

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 7, 2023
• Primary Completion (ANTICIPATED): April 30, 2025
• Study Completion (ANTICIPATED): April 30, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (ACTUAL): December 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: remote monitoring; Novel Wearable Device; Right heart catheterization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2022-NHLHCRF-YXHZ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No