Novel Wearable Device for Heart Failure Management

NCT ID: NCT05642650

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2025-04-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Novel wearable device strategy group

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

Group Type: EXPERIMENTAL

novel wearable device

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

novel wearable 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jingyi Ren

Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Di Sun, Dr.

Role: CONTACT

sundi0929@163.com

010-84206809

Other Identifiers

2022-NHLHCRF-YXHZ-01

Identifier Type: -

Identifier Source: org_study_id