---
title: Novel Wearable Device for Heart Failure Management
nct_id: NCT05642650
overall_status: UNKNOWN
phase: NA
sponsor: China-Japan Friendship Hospital
study_type: INTERVENTIONAL
primary_condition: Heart Failure
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05642650.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05642650"
ct_last_update_post_date: 2023-02-08
last_seen_at: "2026-05-12T06:04:17.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05642650](https://clinicaltrials.gov/study/NCT05642650)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** China-Japan Friendship Hospital
- **Conditions:** Heart Failure
- **Start Date:** 2023-02-07
- **Completion Date:** 2025-04-30
- **CT.gov Last Update:** 2023-02-08

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Novel wearable device strategy group** (EXPERIMENTAL) — Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps.
- **Control group** (NO_INTERVENTION) — Patients receive a standard of care for heart failure without a wearable device.

## Interventions

- **novel wearable device** (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.

## 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

- **Concordance of the Jugular Vein Pressure with the RHC Measurement** _(time frame: Up to 6 months)_
- **Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)** _(time frame: Up to 6 months)_
- **Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.** _(time frame: Up to 6 months)_
- **Compliance Percentage of Patients** _(time frame: Up to 6 months)_
- **Change in Quality of Life** _(time frame: Up to 6 months)_
- **Change in New York Heart Association (NYHA) functional class.** _(time frame: Up to 6 months)_
- **Freedom From a Device/System-related Complication** _(time frame: Up to 6 months)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05642650.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05642650*  
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