Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery

NCT ID: NCT07097168

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-11

Study Completion Date

2026-03-11

Brief Summary

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The goal of this observational study is to use the WHOOP device to measure heart rate variability (HRV) in patients with coronary artery disease (CAD) before and after they have CABG (coronary artery bypass graft) surgery. The main questions it aims to answer are:

* Can changes in HRV, measured by the WHOOP device, help predict how well patients with CAD will recover after CABG surgery?
* Can HRV changes during the hospital stay give doctors useful information about the patient's recovery?

Participants will:

* Wear the WHOOP device before and after their CABG surgery to measure HRV.
* Share their health information to help researchers see how changes in HRV are connected to recovery.

This study will help find out if the WHOOP device can be used as a medical tool to track recovery in patients with CAD after CABG surgery.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Bypass Graft CABG Heart Surgery Heart Disease Coronary Artery Disease WHOOP HRV Heart Rate Variability

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 20 Years or older
* Coronary Artery Disease diagnosis
* Must be scheduled for isolated Coronary Artery Bypass Surgery

Exclusion Criteria

* Acute heart failure
* Acute coronary syndrome (e.g. heart attack/myocardial infarction) in the last 3 months.
* Prior history of heart transplant
* Cardiac assist device (e.g., ventricular assist device, balloon pump)
* Current pacemaker
* Congenital heart disease
* Currently admitted and undergoing treatment for cardiac issues e.g., inotropes, etc,
* Atrial fibrillation
* Frequent premature ventricular complex
* Sinus node dysfunction
* Second and third-degree atrioventricular block
* Combined cardiac surgeries
* Unable to consent.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick C Cobey, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Bellenger CR, Miller DJ, Halson SL, Roach GD, Sargent C. Wrist-Based Photoplethysmography Assessment of Heart Rate and Heart Rate Variability: Validation of WHOOP. Sensors (Basel). 2021 May 20;21(10):3571. doi: 10.3390/s21103571.

Reference Type BACKGROUND
PMID: 34065516 (View on PubMed)

Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.

Reference Type BACKGROUND
PMID: 33390146 (View on PubMed)

Lakusic N, Slivnjak V, Baborski F, Cerovec D. Heart Rate Variability after Off-Pump versus On-Pump Coronary Artery Bypass Graft Surgery. Cardiol Res Pract. 2009;2009:295376. doi: 10.4061/2009/295376. Epub 2009 Sep 1.

Reference Type BACKGROUND
PMID: 19936115 (View on PubMed)

Van Thanh N, Hien NS, Son PN, Son PT. Pattern Changes in the Heart Rate Variability of Patients Undergoing Coronary Artery Bypass Grafting Surgery. Cardiol Res Pract. 2022 Apr 30;2022:1455025. doi: 10.1155/2022/1455025. eCollection 2022.

Reference Type BACKGROUND
PMID: 35535246 (View on PubMed)

Evrengul H, Tanriverdi H, Kose S, Amasyali B, Kilic A, Celik T, Turhan H. The relationship between heart rate recovery and heart rate variability in coronary artery disease. Ann Noninvasive Electrocardiol. 2006 Apr;11(2):154-62. doi: 10.1111/j.1542-474X.2006.00097.x.

Reference Type BACKGROUND
PMID: 16630090 (View on PubMed)

Miller DJ, Sargent C, Roach GD. A Validation of Six Wearable Devices for Estimating Sleep, Heart Rate and Heart Rate Variability in Healthy Adults. Sensors (Basel). 2022 Aug 22;22(16):6317. doi: 10.3390/s22166317.

Reference Type BACKGROUND
PMID: 36016077 (View on PubMed)

Dimeling G, Bakaeen L, Khatri J, Bakaeen FG. CABG: When, why, and how? Cleve Clin J Med. 2021 May 3;88(5):295-303. doi: 10.3949/ccjm.88a.20115.

Reference Type BACKGROUND
PMID: 33941604 (View on PubMed)

Cromwell J, Mitchell JB, Stason WB. Learning by doing in CABG surgery. Med Care. 1990 Jan;28(1):6-18. doi: 10.1097/00005650-199001000-00003.

Reference Type BACKGROUND
PMID: 2404169 (View on PubMed)

Malakar AK, Choudhury D, Halder B, Paul P, Uddin A, Chakraborty S. A review on coronary artery disease, its risk factors, and therapeutics. J Cell Physiol. 2019 Aug;234(10):16812-16823. doi: 10.1002/jcp.28350. Epub 2019 Feb 20.

Reference Type BACKGROUND
PMID: 30790284 (View on PubMed)

Other Identifiers

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STUDY00004109

Identifier Type: -

Identifier Source: org_study_id