Novel Wearable Device for Heart Failure Management

NCT05642650 | Unknown DMC

• 1 other identifier: 2022-NHLHCRF-YXHZ-01
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Novel Wearable Device; remote monitoring; Right heart catheterization

Outcome Measures

Primary Outcomes (1)

• Rate of Hospital Readmissions for Heart Failure

  Total hospitalizations for heart failure will be monitored via follow-up.

  Up to 6 months

Secondary Outcomes (7)

• Concordance of the Jugular Vein Pressure with the RHC Measurement

  Up to 6 months

• Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)

  Up to 6 months

• Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.

  Up to 6 months

• Compliance Percentage of Patients

  Up to 6 months

• Change in Quality of Life

  Up to 6 months

Other Outcomes (2)

• Subjects Included the Endpoint of Cardiovascular Mortality

  Up to 6 months

• Subjects Included the Endpoint of all-cause Mortality

  Up to 6 months

Study Arms (2)

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.

Device: novel wearable device

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.

Novel wearable device strategy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Di Sun, Dr.

CONTACT

010-84206809; sundi0929@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 8, 2022
• Study Start: February 7, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share