NCT04112849

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

September 30, 2019

Last Update Submit

January 25, 2023

Conditions

Heart FailureHeart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Rate of hospital readmissions for 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 Outcomes (1)

  • New York Heart Association (NYHA) functional class during hospital readmissions for heart failure

    90 days from initial hospitalization for acute heart failure

Study Arms (1)

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

Interventions

Measurement of S3 heart soundDIAGNOSTIC_TEST

S3 heart sound to be measured by Nanowear Congestive Heart Failure Management System device.

Heart failure subjects

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2017 Aug;23(8):628-651. doi: 10.1016/j.cardfail.2017.04.014. Epub 2017 Apr 28. No abstract available.

    PMID: 28461259BACKGROUND

  • Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.

    PMID: 20177011BACKGROUND

  • Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidan MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10.

    PMID: 19903931BACKGROUND

  • Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.

    PMID: 17846286BACKGROUND

  • Siejko KZ, Thakur PH, Maile K, Patangay A, Olivari MT. Feasibility of heart sounds measurements from an accelerometer within an ICD pulse generator. Pacing Clin Electrophysiol. 2013 Mar;36(3):334-46. doi: 10.1111/pace.12059. Epub 2012 Dec 17.

    PMID: 23252962BACKGROUND

  • Lloyd T, Buck H, Foy A, Black S, Pinter A, Pogash R, Eismann B, Balaban E, Chan J, Kunselman A, Smyth J, Boehmer J. The Penn State Heart Assistant: A pilot study of a web-based intervention to improve self-care of heart failure patients. Health Informatics J. 2019 Jun;25(2):292-303. doi: 10.1177/1460458217704247. Epub 2017 May 14.

    PMID: 28504048BACKGROUND

  • Buck H, Pinter A, Poole E, Boehmer J, Foy A, Black S, Lloyd T. Evaluating the older adult experience of a web-based, tablet-delivered heart failure self-care program using gerontechnology principles. Geriatr Nurs. 2017 Nov-Dec;38(6):537-541. doi: 10.1016/j.gerinurse.2017.04.001. Epub 2017 May 26.

    PMID: 28554497BACKGROUND

  • Adamson PB, Smith AL, Abraham WT, Kleckner KJ, Stadler RW, Shih A, Rhodes MM; InSync III Model 8042 and Attain OTW Lead Model 4193 Clinical Trial Investigators. Continuous autonomic assessment in patients with symptomatic heart failure: prognostic value of heart rate variability measured by an implanted cardiac resynchronization device. Circulation. 2004 Oct 19;110(16):2389-94. doi: 10.1161/01.CIR.0000139841.42454.78. Epub 2004 Aug 16.

    PMID: 15313946BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John Boehmer, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

March 11, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)