Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation

January 25, 2023 updated by: Milton S. Hershey Medical Center

Electronic S3 Prediction of Hospital Readmissions for Heart Failure Exacerbation

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 hospitalization with a primary diagnosis of heart failure. The main hypothesis of the study is that measurement of S3, using a microelectronic machine microphone positioned in a wearable device (Nanowear Wearable Congestive Heart Failure Management System) near the time of discharge from a hospitalization for heart failure, can predict which patients will be at high risk for a heart failure event, thereby identifying a group in whom increased surveillance and monitoring may decrease hospital readmissions for worsening heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 clinically as fatigue and dyspnea (shortness of breath). This may in turn result in exercise intolerance and fluid retention. Fluid retention leads to pulmonary congestion and/or peripheral edema [Yancy, 2017]. Cardiac rhythm abnormalities are very common among HF patients. Any new abnormalities that arise in a patient with fluid decompensation prolongs hospitalization as well as increases mortality rates [Lloyd-Jones, 2010; Ross, 2009; Chaudhry, 2015].

Within 5 years of a HF diagnosis, the mortality rate is 50%. The 30 day, 1-year and 5-year mortality rates after HF related hospitalization were 10.4%, 22 % and 42.3 % respectively. Post discharge mortality increased from 4.3% to 6.4% between 1993 and 2005 [Lloyd-Jones, 2010; Ross, 2009]. In 2006, the number of deaths with a mention of HF was as high as it was in 1995. 1 out of every 9 mortalities in the US has HF mentioned as a cause. HF related deaths are approximately 7% of all cardiovascular diseases. In the US, HF related costs exceeded $30 billion in 2013. The average cost per patient for HF related hospitalization was $23,077. Hospitalization after a HF diagnosis happens at least once in 83% of the patients and up to four times in 43% of the patients [Yancy, 2017; Lloyd-Jones, 2010; Ross, 2009].

Heart sounds, and particularly the third heart sound, are well known as specific a very specific clinical signs for heart failure and are associated with worse clinical outcomes. In the context of HF the presence of a pronounced or audible S3 is a specific sign of elevated filling pressures and is suggestive of a restrictive filling pattern with a steep transmitral E-wave [Siejko, 2017]. Recent advances in digital audio technology allow us to not simply assess for the presence or absence of a third heart in objective measures, but also allow us to quantitate it [Buck, 2017; Adamson, 2014; Lloyd, 2019]. Further, recent work has demonstrated that if a frequency range to detect and quantitate the third heart sound is used that extends below the usual range for human hearing, that the third heart sound may be even more predictive of clinical outcomes. The investigators are working with a device manufacturer who have a wearable diagnostic device that includes a directional microelectronic machine microphone that can effectively detect heart sounds. This device will be used to detect and quantitate heart sounds, and specifically the third heart sound, to investigate the prognostic implications of a third heart sound.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, 18 and older, admitted to the hospital with a primary diagnosis of acute heart failure and NYHA class II-IV at time of enrollment.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart failure subjects
Subjects who have heart failure, and meet inclusion/exclusion criteria, who will be enrolled in this study and will have their heart sounds measured with Nanowear vest (NCHFMS).
Diagnostic test: Measurement of S3 heart sound
S3 heart sound to be measured by Nanowear Congestive Heart Failure Management System device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospital readmissions for heart failure
Time Frame: 90 days from initial hospitalization for acute heart failure
Total hospitalizations will be monitored from time patient is initially discharged for acute heart failure until 90 days post-discharge.
90 days from initial hospitalization for acute heart failure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New York Heart Association (NYHA) functional class during hospital readmissions for heart failure
Time Frame: 90 days from initial hospitalization for acute heart failure
If applicable, New York Heart Association (NYHA) functional class 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.
90 days from initial hospitalization for acute heart failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: John Boehmer, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY12419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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