CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 176 enrolled
Drug / intervention
Remote monitoring and predictive analytics +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04502563
NCT04502563N/ACompleted

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

VA Office of Research and Development·interventional·Posted Aug 6, 2020·Updated Apr 28, 2026

In Brief

A clinical study evaluating Remote monitoring and predictive analytics and Sham comparator for Heart Failure. Completed, enrolled 176 participants across 4 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartApr 19, 2021
Primary CompletionAug 31, 2024
Study CompletionOct 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.9 years ago

Interventions

Remote monitoring and predictive analyticsother

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.

Sham comparatorother

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