Status:
COMPLETED
LINK-HF2 - Remote Monitoring Analytics in Heart Failure
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
George E. Wahlen Department of Veterans Affairs Medical Center
Michael E. DeBakey VA Medical Center
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inve...
Detailed Description
Heart failure (HF) represents a major health burden, with 80% of the HF health care costs attributable to hospitalizations. In a pilot multicenter study funded by the VA Center for Innovation, the inv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04502563
Start Date
April 19 2021
End Date
October 30 2024
Last Update
December 10 2024
Active Locations (4)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
2
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
3
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
4
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249-0001