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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

LINK-HF2 - Remote Monitoring Analytics in Heart Failure

NCT04502563

Heart Failure

COMPLETED NA

Determine Return on Investment in Heart Failure Remote Monitoring Program

NCT02475577

Heart Failure

UNKNOWN NA

Screening for Heart Failure Using a Multimodal Wearable Device

NCT06335264

Heart Failure

COMPLETED

The CASCADE HF Soft Launch and Calibration Phase I and II

NCT04738279

Heart Failure

COMPLETED PHASE2/PHASE3

Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

NCT02343523

Heart Failure

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HealthPatch

A multi-sensor device to collect continuous vital signs

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No