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

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

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.

Condition or disease Intervention/treatment
Cardiac Failure Device: HealthPatch

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.


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Link-HF, Phase II: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation
Study Start Date : June 2015
Actual Primary Completion Date : January 26, 2017
Actual Study Completion Date : January 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: HealthPatch
    A multi-sensor device to collect continuous vital signs


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with heart failure, NYHA Class II-IV
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037710


Locations
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United States, California
Palo Alto VA Health Care System
Palo Alto, California, United States, 94304
United States, Florida
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Utah
George E Wahlen Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
Josef Stehlik
Investigators
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Principal Investigator: Josef Stehlik, MD University of Utah

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Responsible Party: Josef Stehlik, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03037710     History of Changes
Other Study ID Numbers: 81833
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases