Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation

Heart Failure Clinical Trial

Official title:

Electronic S3 Prediction of Hospital Readmissions for Heart Failure Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112849
• Other study ID #: STUDY12419
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Reduced Ejection Fraction

Intervention

Diagnostic Test:
• Measurement of S3 heart sound
S3 heart sound to be measured by Nanowear Congestive Heart Failure Management System device.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Circulation. 2010 Mar 30;121(12):e259. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	New York Heart Association (NYHA) functional class during hospital readmissions for 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