Status:

WITHDRAWN

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

Lead Sponsor:

Milton S. Hershey Medical Center

Conditions:

Heart Failure

Heart Failure With Reduced Ejection Fraction

Eligibility:

All Genders

18-99 years

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: (...

Detailed Description

Heart Failure (HF) is a challenging condition to manage, with hospital readmission for HF exacerbation having negative impacts on patient outcomes and financial burden to both patient and health syste...

Eligibility Criteria

Inclusion

  • Subject has provided informed consent
  • Male or female over the age of 18 years
  • 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.
  • NYHA functional class II-IV at time of enrollment
  • Subject willing to wear the WHOOP for the 90-day study period.
  • Subject owns a phone for pairing with the WHOOP device (required for data storage and transfer)

Exclusion

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

Key Trial Info

Start Date :

March 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 14 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04455828

Start Date

March 1 2021

End Date

April 14 2022

Last Update

January 26 2023

Active Locations (1)

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033