Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 108
- Primary Endpoint
- Rate of Hospital Readmissions for Heart Failure
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Rate of Hospital Readmissions for Heart Failure
Time Frame: Up to 6 months
Total hospitalizations for heart failure will be monitored via follow-up.
Secondary Outcomes
- Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)(Up to 6 months)
- Concordance of the Jugular Vein Pressure with the RHC Measurement(Up to 6 months)
- Compliance Percentage of Patients(Up to 6 months)
- Freedom From a Device/System-related Complication(Up to 6 months)
- Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.(Up to 6 months)
- Change in Quality of Life(Up to 6 months)
- Change in New York Heart Association (NYHA) functional class.(Up to 6 months)
Investigators
Jingyi Ren
Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center
China-Japan Friendship Hospital