Apple Watch Heart Failure Study

NCT04510779 | Completed

• 1 other identifier: AppleWatch
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Heart Failure Patients

EXPERIMENTAL

This will be a single arm study of heart failure patients with acute decompensation

Device: Apple Watch

Interventions

Apple Watch DEVICE

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

Heart Failure Patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 22
• Patients admitted to Tufts Medical Center for acute decompensated heart failure
• Left ventricular ejection fraction greater than 35%
• Able to consent

You may not qualify if:

• Pacemaker rhythm
• Arrhythmia, e.g. atrial fibrillation, atrial flutter, frequent ectopic beats
• prior history of heart transplant or ventricular assist device
• pregnant

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (11)

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

  PMID: 23989710 BACKGROUND

• 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.

  PMID: 22331920 BACKGROUND

• 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.

  PMID: 18550924 BACKGROUND

• 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.

  PMID: 8737210 BACKGROUND

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

  PMID: 14502297 BACKGROUND

• 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.

  PMID: 28396041 BACKGROUND

• 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.

  PMID: 24490775 BACKGROUND

• 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.

  PMID: 21496161 BACKGROUND

• 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.

  PMID: 19690410 BACKGROUND

• 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.

  PMID: 30103376 BACKGROUND

• 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.

  PMID: 22642636 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: May 9, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)