Status:

COMPLETED

Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation

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 study objective is to measure the value of the third heart sound (S3) for the prediction of recurrent heart failure (HF). For the purpose of this study, a heart failure event will be defined as a ...

Detailed Description

Heart failure (HF) is a complex clinical syndrome that results from any structural or functional impairment of the heart that affects the filling or ejection of blood in a cardiac cycle. HF manifests ...

Eligibility Criteria

Inclusion

  • Inclusion 1. Subject has provided informed consent
  • Inclusion 2. Male or female over the age of 18 years
  • Inclusion 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.
  • Inclusion 4. NYHA functional class II-IV at time of enrollment
  • Inclusion 5. Subjects were patients of Penn State Hershey Medical Center (PSHMC), who are/were admitted at PSHMC.

Exclusion

  • Exclusion 1. Subject unwilling or unable to wear the system for one measurement prior to discharge or within the first two weeks following discharge.
  • Exclusion 2. Subjects who are limited by angina.
  • Exclusion 3. Severe aortic stenosis.
  • Exclusion 4. Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
  • Exclusion 5. Symptomatic ventricular arrhythmias within the past 6 months.

Key Trial Info

Start Date :

March 11 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2022

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT04112849

Start Date

March 11 2020

End Date

September 1 2022

Last Update

January 26 2023

Active Locations (1)

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1

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033