Link-HF, Phase II: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation (LINK-HF)

• ClinicalTrials.gov Identifier: NCT03037710
• Recruitment Status: Completed
• First Posted: January 31, 2017
• Last Update Posted: January 9, 2018
• Sponsor: Josef Stehlik
• Information provided by (Responsible Party): Josef Stehlik, University of Utah

Tracking Information

• First Submitted Date: January 27, 2017
• First Posted Date: January 31, 2017
• Last Update Posted Date: January 9, 2018
• Study Start Date: June 2015
• Actual Primary Completion Date: January 26, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2017)

Detection of Heart Failure Exacerbation Event [ Time Frame: 90 Days ]

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03037710 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Link-HF, Phase II: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation
• Official Title: Link-HF, Phase II: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation
• 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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Individuals with heart failure, NYHA Class II-IV
• Condition: Cardiac Failure

Intervention

Device: HealthPatch

A multi-sensor device to collect continuous vital signs

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2017): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 26, 2017
• Actual Primary Completion Date: January 26, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03037710
• Other Study ID Numbers: 81833
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Josef Stehlik, University of Utah
• Study Sponsor: Josef Stehlik
• Collaborators: Not Provided

Investigators

• Principal Investigator: Josef Stehlik, MD; University of Utah

• PRS Account: University of Utah
• Verification Date: January 2018