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Novel Wearable Device for Heart Failure Management

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
novel wearable device
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Heart Failure focused on measuring Novel Wearable Device, remote monitoring, Right heart catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Subjects with eGFR < 25 mL/min/1.73m2 Pregnant women, or women likely to undergo pregnancy Subjects with life expectancy less than 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Novel wearable device strategy group

    Control group

    Arm Description

    Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps.

    Patients receive a standard of care for heart failure without a wearable device.

    Outcomes

    Primary Outcome Measures

    Rate of Hospital Readmissions for Heart Failure
    Total hospitalizations for heart failure will be monitored via follow-up.

    Secondary Outcome Measures

    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.
    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.
    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.
    Compliance Percentage of Patients
    Patient adherence to daily measurement and transmission of sensor readings will be recorded.
    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.
    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.
    Freedom From a Device/System-related Complication
    Device/System-related Complications refer to adverse events such as device failure and allergy.

    Full Information

    First Posted
    November 15, 2022
    Last Updated
    February 7, 2023
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05642650
    Brief Title
    Novel Wearable Device for Heart Failure Management
    Official Title
    Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 7, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Novel Wearable Device, remote monitoring, Right heart catheterization

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Novel wearable device strategy group
    Arm Type
    Experimental
    Arm Description
    Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients receive a standard of care for heart failure without a wearable device.
    Intervention Type
    Device
    Intervention Name(s)
    novel wearable device
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rate of Hospital Readmissions for Heart Failure
    Description
    Total hospitalizations for heart failure will be monitored via follow-up.
    Time Frame
    Up to 6 months
    Secondary Outcome Measure Information:
    Title
    Concordance of the Jugular Vein Pressure with the RHC Measurement
    Description
    Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization.
    Time Frame
    Up to 6 months
    Title
    Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
    Description
    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
    Title
    Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
    Description
    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
    Title
    Compliance Percentage of Patients
    Description
    Patient adherence to daily measurement and transmission of sensor readings will be recorded.
    Time Frame
    Up to 6 months
    Title
    Change in Quality of Life
    Description
    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
    Title
    Change in New York Heart Association (NYHA) functional class.
    Description
    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
    Title
    Freedom From a Device/System-related Complication
    Description
    Device/System-related Complications refer to adverse events such as device failure and allergy.
    Time Frame
    Up to 6 months
    Other Pre-specified Outcome Measures:
    Title
    Subjects Included the Endpoint of Cardiovascular Mortality
    Description
    Rate of cardiovascular mortality will be monitored via follow-up.
    Time Frame
    Up to 6 months
    Title
    Subjects Included the Endpoint of all-cause Mortality
    Description
    Rate of all-cause mortality will be monitored via follow-up.
    Time Frame
    Up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Subjects with eGFR < 25 mL/min/1.73m2 Pregnant women, or women likely to undergo pregnancy Subjects with life expectancy less than 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Di Sun, Dr.
    Phone
    010-84206809
    Email
    sundi0929@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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