Apple Watch Heart Failure Study

Heart Failure Clinical Trial

Official title:

Monitoring Heart Failure Patients Using Heart Rate Variability Measured by the Apple Watch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510779
• Other study ID #: AppleWatch
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot/feasibility study on the accuracy of HRV as measured by the Apple Watch on heart failure patients who are admitted to the hospital with heart failure exacerbation. The primary aim is to observe a statistically significant improvement in the HRV of acutely decompensated heart failure patients upon discharge when compared to admission, implying the utility of HRV measured by Apple Watch as a monitor for cardiovascular health.

Description:

Heart failure (HF) is a complex clinical syndrome. It is caused by structural or functional impairments, which interfere with the ability of heart muscles to fill or eject blood. The prevalence of HF exceeds 7 million in the United States alone.(1) Despite improving survival, HF hospitalization rates has remained stable, which reflects persisting difficulties in managing existing disease. (2) Specifically, readmission rates may be as high as 50% by 6 months after an admission for HF management. (2) Caring for HF patients exceeds 30 billion annually and is largely driven by hospitalizations.2 Innovative, at-home surveillance tools are needed to reduce hospital admissions and to drive down the overall societal burden of this disease. (3)

HF is characterized by periodic exacerbations due to volume overload and fluid congestion that impairs perfusion to the organs.(2) Accurate assessment of volume status is, therefore, key for early detection of impending exacerbation. Currently, there is no single, objective method of assessment, relying on a combination of tools including physical examination, weight, pulmonary artery catheter or echocardiography.(4) However, these measures are subjective, invasive, or impractical for monitoring patients at home. Unique body habitus and comorbidities of individual patient further complicates assessment of volume status.(4) The future of heart failure management, therefore, lies in the development of a telemonitoring system that is convenient to use and accessible for patients at home, while quantitatively understanding individual characteristics.(4)

Cardiovascular health is closely related to the imbalances of the autonomic nervous system.(5) Heart rate variability (HRV), the degree of fluctuation in the interval between consecutive heartbeats, has been recognized as a reliable marker of autonomic activity.(5) HRV has been shown to be depressed in patients with congestive heart failure (CHF) and to correlate with disease severity. (6) Furthermore, abnormal HRV parameters are independently associated with incident CHF in asymptomatic, older adults. (7)

HRV is conventionally measured using a 24-hour Holter monitor, which is sensitive, but inconvenient and impractical for home monitoring.(5) Newer studies have shown not only the reliability of short term (5-minute) or ultra-short term (<5 minute) analysis of electrocardiographic recordings, but also that of wearable monitors amenable for use at home.(9-11) In particular, HRV parameters measured by Apple Watch (Cupertino, California) were shown to agree with those measured by a validated chest best heart rate monitor.(12)

The usefulness of the study is to validate the utility of wearable heart monitors such as the Apple Watch in accurately measuring heart rate variability, a dynamic marker of cardiovascular health, and correlating it with the health status specifically of heart failure patients. Validating this will allow wearable monitors to record HRV remotely from home, facilitating telemonitoring and preventing hospitalizations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Age > or = 22

• Patients admitted to Tufts Medical Center for acute decompensated heart failure

• Left ventricular ejection fraction greater than 35%

• Able to consent

Exclusion Criteria:

• Pacemaker rhythm

• Arrhythmia, e.g. atrial fibrillation, atrial flutter, frequent ectopic beats

• prior history of heart transplant or ventricular assist device

• pregnant

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Apple Watch
Apple Watch is a smartwatch developed by Apple Inc. The heart rate variability function will be used.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

Desai AS. Home monitoring heart failure care does not improve patient outcomes: looking beyond telephone-based disease management. Circulation. 2012 Feb 14;125(6):828-36. doi: 10.1161/CIRCULATIONAHA.111.031179. No abstract available. — View Citation

Ferrario M, Moissl U, Garzotto F, Cruz DN, Clementi A, Brendolan A, Tetta C, Gatti E, Signorini MG, Cerutti S, Ronco C. Effects of fluid overload on heart rate variability in chronic kidney disease patients on hemodialysis. BMC Nephrol. 2014 Feb 4;15:26. doi: 10.1186/1471-2369-15-26. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available. — View Citation

Hernando D, Roca S, Sancho J, Alesanco A, Bailon R. Validation of the Apple Watch for Heart Rate Variability Measurements during Relax and Mental Stress in Healthy Subjects. Sensors (Basel). 2018 Aug 10;18(8):2619. doi: 10.3390/s18082619. — View Citation

Karp E, Shiyovich A, Zahger D, Gilutz H, Grosbard A, Katz A. Ultra-short-term heart rate variability for early risk stratification following acute ST-elevation myocardial infarction. Cardiology. 2009;114(4):275-83. doi: 10.1159/000235568. Epub 2009 Aug 18. — View Citation

Murray CM, Agha SA, Rathi S, Germany RE. The evaluation and monitoring of volume status in congestive heart failure. Congest Heart Fail. 2008 May-Jun;14(3):135-40. doi: 10.1111/j.1751-7133.2008.05640.x. — View Citation

Musialik-Lydka A, Sredniawa B, Pasyk S. Heart rate variability in heart failure. Kardiol Pol. 2003 Jan;58(1):10-6. — View Citation

Nussinovitch U, Elishkevitz KP, Katz K, Nussinovitch M, Segev S, Volovitz B, Nussinovitch N. Reliability of Ultra-Short ECG Indices for Heart Rate Variability. Ann Noninvasive Electrocardiol. 2011 Apr;16(2):117-22. doi: 10.1111/j.1542-474X.2011.00417.x. — View Citation

Patel VN, Pierce BR, Bodapati RK, Brown DL, Ives DG, Stein PK. Association of Holter-Derived Heart Rate Variability Parameters With the Development of Congestive Heart Failure in the Cardiovascular Health Study. JACC Heart Fail. 2017 Jun;5(6):423-431. doi: 10.1016/j.jchf.2016.12.015. Epub 2017 Apr 5. — View Citation

Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268. — View Citation

Tanindi A, Olgun H, Celik B, Boyaci B. Heart rate variability in patients hospitalized for decompensated diastolic heart failure at admission and after clinical stabilization. Future Cardiol. 2012 May;8(3):473-82. doi: 10.2217/fca.12.24. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of Standard Deviation of NN Intervals upon Discharge Compared to Admission	Standard Deviation of NN Intervals is a time domain heart rate variability parameter. The value upon discharge after medical management should be statistically greater compared to admission value.	1-2 Weeks