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COMPLETED
NCT04502563
NA

LINK-HF2 - Remote Monitoring Analytics in Heart Failure

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Heart failure (HF) is a type of heart disease that leads to need of admissions to the hospital during worsening of symptoms. These admissions are expensive and very inconvenient for patients. The investigators have previously shown that monitoring of patients with a using a small wearable sensor combined with a mathematical model can detect worsening of HF before the patient needs medical care. In this study the investigators will test whether the remote monitoring and prediction of HF worsening can be used to find out when patients are at risk, change their treatment and avoid a hospitalization. The study will enroll 240 Veterans with HF and randomly assign half of them to monitoring and communication of the information on HF worsening to their medical teams. The investigators hope to find our how to best use this approach in routine care of HF. The investigators also plan to determine if this approach will indeed led to less admissions to the hospital among these patients, shorter hospital stays and better quality of life.

Official title: Continuous Wearable Monitoring Analytics to Improve Outcomes in Heart Failure - LINK-HF2 Multicenter Implementation Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2021-04-19

Completion Date

2024-10-30

Last Updated

2026-04-28

Healthy Volunteers

No

Conditions

Interventions

OTHER

Remote monitoring and predictive analytics

Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.

OTHER

Sham comparator

Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.

Locations (4)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States