NCT04502563Completed
LINK-HF2 - Remote Monitoring Analytics in Heart Failure
Continuous Wearable Monitoring Analytics to Improve Outcomes in Heart Failure - LINK-HF2 Multicenter Implementation Study
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 4 Aug 2020
- Start date
- 19 Apr 2021
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Heart failure
- NCT number
- NCT04502563
What you commit to
- Study type: Interventional
- Participants enrolled: 176
- From 19 Apr 2021 to the primary completion date, 31 Aug 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Expected Left Ventricular Assist Device implantation or heart transplantation in the next 30 days.
- Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body.
- Visual/cognitive impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol.
Other
- Skin damage or significant arthritis, preventing wearing of device.
- Pregnant women or those who are currently nursing.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| VA Palo Alto Health Care System, Palo Alto, CA Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| VA Salt Lake City Health Care System, Salt Lake City, UT Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
Related publications
- Artificial Intelligence-Enabled Detection and Management of Physiological Instability in Heart Failure: Results of the Randomized LINK-HF2 Trial.JACC Heart Fail · 2026 · PMID 42853165
This page is information, not medical advice. Discuss any trial with your doctor.