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

Completed

• Conditions: Cardiac Failure

• Registration Number: NCT03037710
• Lead Sponsor: Josef Stehlik

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.

Detailed Description

The analytics being investigated includes a Similarity-Based Modeling technique, that empirically estimates the expected physiological behavior of a subject based on prior learned dynamic data, for comparison to actual measured behavior from the subject, to reveal discrepancies hidden by normal variation. The measurements are typically an ensemble of vital signs that effectively characterizes the physiological "control system" of the subject. This technique is multivariate: multiple variables are leveraged, because single variables in isolation have little context - a high heart rate by itself could mean a person is exerting himself, or it could mean his physiology is in distress even though he is not exerting himself. With reference to several other variables, however, such as respiration rate, oximetry and motion/activity, a high heart rate might be recognized as a normal state when accompanied by the corroborating data showing a high respiration rate, a normal oximetry and a high level of motion - the person is exercising.

A wearable adhesive multi-sensor device will be used to collect continuous vital sign and other data from study subjects, including heart rate, respiration rate, bodily motion/activity, skin temperature, pulse, electrocardiogram and peripheral capillary oxygen saturation. Subjects are provided with a smartphone or cellular tablet that will be paired with the multi-sensor device to receive data and upload it to the analytics server via cellular network or WiFi internet. Study staff will interact with the subject during visits scheduled for routine heart failure follow-up to capture pre-specified heart failure medical events. All standard of care clinic and hospitalization notes and procedure reports including echocardiograms, right heart catheterizations, pulmonary function tests, six minute walk tests and radiology reports will be collected as they occur.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2017-01-26
• Study Completion: 2017-01-26
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subject must be 18 years old or older
2. NYHA( New York Heart Association Functional Classification) Class II-IV, documented in site's medical record system.
3. Subject able and willing to sign Informed Consent Document.
4. Subject willing and able to perform all study related procedures.

Exclusion Criteria

1. Expected LVAD (Left Ventricular Assist Device) implantation or heart transplantation in the next 30 days.
2. Skin damage or significant arthritis, preventing wearing of device.
3. Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body.
4. Pregnant women or those who are currently nursing.
5. Visual/cognitive impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of Heart Failure Exacerbation Event	90 Days	Correlation of algorithmic alerts generated by a non-invasive telemonitoring system to a verified heart failure exacerbation event, measured in percent accuracy

Trial Locations

Locations (4)

George E Wahlen Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

Palo Alto VA Health Care System; 🇺🇸 Palo Alto, California, United States

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States