LINK-HF2 - Remote Monitoring Analytics in Heart Failure

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.

Conditions

• Heart Failure

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.

Sponsors & Collaborators

• George E. Wahlen Department of Veterans Affairs Medical Center

  collaborator UNKNOWN

• Michael E. DeBakey VA Medical Center

  collaborator FED

• VA Palo Alto Health Care System

  collaborator FED

• Malcom Randall VA Medical Center

  collaborator FED

• Hunter Holmes McGuire VA Medical Center

  collaborator FED

• VHA Innovation Ecosystem

  collaborator UNKNOWN

• VA Office of Research and Development

  lead FED

Principal Investigators

• Josef Stehlik, MD MPH · VA Salt Lake City Health Care System, Salt Lake City, UT

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-19

Primary Completion

2024-08-31

Completion

2024-10-30

Countries

• United States

Study Locations