Novel Wearable Device for Heart Failure Management

Last updated: February 7, 2023
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT05642650
2022-NHLHCRF-YXHZ-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 108
Study Start date:
February 07, 2023
Estimated Completion Date:
April 30, 2025

Study 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.