Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037710
Other study ID # 81833
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date January 26, 2017

Study information

Verified date August 2020
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 26, 2017
Est. primary completion date January 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Malcom Randall VA Medical Center Gainesville Florida
United States Michael E. DeBakey VA Medical Center Houston Texas
United States Palo Alto VA Health Care System Palo Alto California
United States George E Wahlen Medical Center Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Josef Stehlik

Country where clinical trial is conducted

United States, 

References & 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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03799133 - Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT02524574 - Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure N/A
Active, not recruiting NCT03841084 - Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial Phase 2
Terminated NCT02459054 - Syncardia 50cc TAH-t as a Bridge to Transplant N/A
Terminated NCT02859636 - Pronostic Value of Endothelial Dysfunction in Heart Failure N/A
Completed NCT04599816 - Levosimendan Administration in Pulmonary Hypertension N/A
Recruiting NCT05761639 - Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation N/A
Not yet recruiting NCT04696523 - Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage Phase 2
Completed NCT03357731 - A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function Phase 2
Completed NCT02331264 - Cardiac Assessment of Patients With Hip Implants N/A
Terminated NCT01921829 - Protocolized Diuretic Strategy in Cardiorenal Failure Phase 4
Completed NCT06197256 - Cardiac Dysfunction in Critically Ill Covid-19 Patients
Recruiting NCT03197792 - Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy N/A
Completed NCT03515980 - An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function Phase 1
Completed NCT03212898 - Pharmacist Interventions in Rural Elderly Warfarin Patients N/A
Completed NCT03243604 - cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study
Completed NCT06330103 - Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips N/A
Completed NCT02660385 - Insomnia Self-Management in Heart Failure N/A