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N/A N=176 Randomized Quadruple-blind Health Services Research

LINK-HF2 - Remote Monitoring Analytics in Heart Failure

Heart Failure

Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Heart Failure Hospitalization Rate — 13; 16 Heart failure hospitalizations

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Remote monitoring and predictive analytics (Other); Sham comparator (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Heart Failure Hospitalization Rate
13; 16
SECONDARY
Kansas City Cardiomyopathy Questionaire Score

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04502563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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