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Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455828
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
John Boehmer, Milton S. Hershey Medical Center

Brief Summary:
The primary objective of this study is to study in heart failure (HF) patients to better assess HF disease state, which can aid in management and improve outcomes. Primary aims of the study include: (1) Measure HR and RR at rest and during daily activity using the WHOOP device. (2) Correlate HR and RR response to activity to New York Heart Association (NYHA) class and 90-day HF hospitalization rate. (3) Identify additional predictors of NYHA class and HF hospitalization rate for algorithm development to use the WHOOP device as a clinical tool for HF management.

Condition or disease Intervention/treatment
Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Device: WHOOP strap 3.0

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Hospitalized Heart Failure subjects
Subjects hospitalized for heart failure exacerbation will be enrolled, prior to discharge from hospital, to wear the WHOOP device for 90 days.
Device: WHOOP strap 3.0
WHOOP strap 3.0, a photodiode-based device that tracks heart rate, respiratory rate, sleep, and heart rate variability.

Non-hospitalized Heart Failure subjects
Subjects who have not been hospitalized in the past 1 year, but have a diagnosis of heart failure, will be enrolled during routine outpatient care to wear the WHOOP device for 90 days.
Device: WHOOP strap 3.0
WHOOP strap 3.0, a photodiode-based device that tracks heart rate, respiratory rate, sleep, and heart rate variability.




Primary Outcome Measures :
  1. Daily average heart rate (HR) [ Time Frame: 90 days ]
    Daily average heart rate (HR) measured by the WHOOP device. This will be continuously measured for 90 days.

  2. Daily average respiratory rate (RR) [ Time Frame: 90 days ]
    Daily average respiratory rate (RR) measured by the WHOOP device. This will be continuously measured for 90 days

  3. Heart Failure (HF) hospitalizations [ Time Frame: 90 days ]
    Hospital admission for the primary diagnosis for acute, or acute on chronic heart failure) will be assessed via Electronic Medical Record (EMR) and a 90-day patient follow up visit.


Secondary Outcome Measures :
  1. Average HR isolated during any activity [ Time Frame: 90 days ]
    Average HR isolated during any activity lasting greater than 15 minutes (causing at least a 20% increase in heart rate over baseline), for the duration of the activity, measured by the WHOOP device. This will be recorded according to HR gating measures (20% over baseline HR) for the entire 90-day follow up period.

  2. Max HR isolated during any activity [ Time Frame: 90 days ]
    Max HR isolated during any activity lasting greater than 15 minutes (causing at least a 20% increase in heart rate over baseline), for the duration of the activity, measured by the WHOOP device. This will be recorded according to HR gating measures (20% over baseline HR) for the entire 90-day follow up period.

  3. Average RR isolated during any activity [ Time Frame: 90 days ]
    Average RR isolated during any activity lasting greater than 15 minutes (causing at least a 20% increase in heart rate over baseline), for the duration of the activity, measured by the WHOOP device. This will be recorded according to HR gating measures (20% over baseline HR) for the entire 90-day follow up period.

  4. Max RR isolated during any activity [ Time Frame: 90 days ]
    Max RR isolated during any activity lasting greater than 15 minutes (causing at least a 20% increase in heart rate over baseline), for the duration of the activity, measured by the WHOOP device. This will be recorded according to HR gating measures (20% over baseline HR) for the entire 90-day follow up period.

  5. New York Heart Association (NYHA) functional HF class [ Time Frame: 90 days ]
    New York Heart Association (NYHA) functional HF class will be measured at baseline and, if applicable, will be assessed during readmission for heart failure. NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity; Class I being best and Class IV being the worst functional class. Class I has no limitation to physical activity, Class II has slight limitation to physical activity, Class III has marked limitation of physical activity, and Class IV is unable to carry out any physical activity without severe discomfort. This will also be repeated at 90-day follow up. Higher NYHA class is expected to be associated with increases in average HR and RR and HR and RR increases with activity, and increased HF hospitalization rate.

  6. 6-minute walk test [ Time Frame: 90 days ]
    6-minute walk test is used to assess exercise tolerance and hypoxia with ambulation. Decreased exercise tolerance and increased hypoxia with walking are expected to be associated with worse NYHA HF class, increases in average HR and RR and HR and RR increases with activity, and increased HF hospitalization rate.

  7. NT-proBNP (N-terminal-pro hormone B-type natriuretic peptide) [ Time Frame: 90 days ]
    NT-proBNP is used to assess atrial stretch, a surrogate for acute, chronic, or acute on chronic HF. Increased NT-proBNP (compared to baseline) is expected to correlate with worse NYHA HF class, increases in average HR and RR and HR and RR increases with activity, and increased HF hospitalization rate.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients, 18 and older, admitted to the hospital with a primary diagnosis of acute heart failure or any stable patient who presents for routine outpatient care, but has a diagnosis of Heart Failure, and is NYHA class II-IV at time of enrollment.
Criteria

Inclusion Criteria:

  1. Subject has provided informed consent
  2. Male or female over the age of 18 years
  3. The patient is either hospitalized with a primary diagnosis of acute heart failure or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment; or carries a diagnosis of heart failure and is seen as an outpatient at Hershey Medical Center.
  4. NYHA functional class II-IV at time of enrollment
  5. Subject willing to wear the WHOOP for the 90-day study period.
  6. Subject owns a phone for pairing with the WHOOP device (required for data storage and transfer)

Exclusion Criteria:

  1. Subjects who are limited by angina.
  2. Subjects with severe aortic stenosis.
  3. Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
  4. Subjects with symptomatic ventricular arrhythmias within the past 6 months.

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): NCT04455828


Contacts
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Contact: Alexander Hajduczok, MD 7175315160 ahajduczok@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: John Boehmer, MD Milton S. Hershey Medical Center
Additional Information:
Publications:

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Responsible Party: John Boehmer, Professor, Cardiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04455828    
Other Study ID Numbers: STUDY15557
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Boehmer, Milton S. Hershey Medical Center:
Heart Failure
Remote Monitoring
WHOOP strap 3.0
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases