Link-HF: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation

NCT03037710 | Completed

• 1 other identifier: 81833
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, non-randomized, non-interventional study to evaluate the accuracy of a remote monitoring and analytical platform for prediction of heart failure exacerbation. The platform acquires continuous multivariate vital signs from HF patients using a new ambulatory wearable (attached by an adhesive) multi-sensor device and analyzes the data using a novel machine learning algorithm.

Conditions

Cardiac Failure

Outcome Measures

Primary Outcomes (1)

• Detection of Heart Failure Exacerbation Event

  Correlation of algorithmic alerts generated by a non-invasive telemonitoring system to a verified heart failure exacerbation event, measured in percent accuracy

  90 Days

Interventions

HealthPatch DEVICE

A multi-sensor device to collect continuous vital signs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with heart failure, NYHA Class II-IV

You may qualify if:

• 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.
• Subject willing and able to perform all study related procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josef Stehlik: lead

Study Sites (4)

Palo Alto VA Health Care System

Palo Alto, California, 94304, United States

Location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

George E Wahlen Medical Center

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

• Stehlik J, Schmalfuss C, Bozkurt B, Nativi-Nicolau J, Wohlfahrt P, Wegerich S, Rose K, Ray R, Schofield R, Deswal A, Sekaric J, Anand S, Richards D, Hanson H, Pipke M, Pham M. Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization: The LINK-HF Multicenter Study. Circ Heart Fail. 2020 Mar;13(3):e006513. doi: 10.1161/CIRCHEARTFAILURE.119.006513. Epub 2020 Feb 25.

  PMID: 32093506 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Josef Stehlik, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: June 1, 2015
• Primary Completion: January 26, 2017
• Study Completion: January 26, 2017
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)