LINK-HF2 - Remote Monitoring Analytics in Heart Failure

Completed · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04502563

Run by

VA Office of Research and Development

People needed

176

Starts

2021-04-19

Expected to finish

2024-10-30

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be 18 years old or older
• New York Heart Association Functional Classification Class II-IV, documented in site's medical record system.
• Subject able and willing to sign Informed Consent Document, and if participating in a patient interview, able to comprehend and agree with items listed in the VA Consent Cover Letter.
• Subject willing and able to perform all study related procedures.

You may not qualify if…

• Expected Left Ventricular Assist Device implantation or heart transplantation in the next 30 days.
• Skin damage or significant arthritis, preventing wearing of device.
• Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body.
• Pregnant women or those who are currently nursing.
• Visual/cognitive impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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