Clinical trial NCT05642650: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Novel Wearable Device
remote monitoring
Right heart catheterization
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Hospital Readmissions for Heart Failure
timeFrame: Up to 6 months
Secondary outcomes:
measure: Concordance of the Jugular Vein Pressure with the RHC Measurement
timeFrame: Up to 6 months
measure: Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
timeFrame: Up to 6 months
measure: Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
timeFrame: Up to 6 months
measure: Compliance Percentage of Patients
timeFrame: Up to 6 months
measure: Change in Quality of Life
timeFrame: Up to 6 months
measure: Change in New York Heart Association (NYHA) functional class.
timeFrame: Up to 6 months
measure: Freedom From a Device/System-related Complication
timeFrame: Up to 6 months
Other outcomes:
measure: Subjects Included the Endpoint of Cardiovascular Mortality
timeFrame: Up to 6 months
measure: Subjects Included the Endpoint of all-cause Mortality
timeFrame: Up to 6 months
Locations:
Study officials:
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