LINK-HF2 - Remote Monitoring Analytics in Heart Failure
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
🗓️ Study Start (Actual) 19 April 2021
🗓️ Primary Completion (Estimated) 30 October 2024
✅ Study Completion (Estimated) 30 October 2024
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Palo Alto, California, United States
📍 Gainesville, Florida, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Richmond, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Subject must be 18 years old or older
    • * NYHA( 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 LVAD (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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 August 2020
  • First Submitted that Met QC Criteria 4 August 2020
  • First Posted 6 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 March 2024
  • Last Update Posted 26 March 2024
  • Last Verified March 2024