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

Withdrawn

• Conditions: Coronary Artery Disease

• Registration Number: NCT07097168
• Lead Sponsor: Tufts Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Study Start: 2025-06-11
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2026-01-11
• Study Completion: 2026-03-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Participants will be excluded if they have the following;

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability (HRV) Before and After CABG Surgery	- Pre-operative, Up to 1 hour before surgery (Measurement taken in the pre-op area) - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.	The primary goal of this study is to assess how heart rate variability (HRV) changes in patients with coronary artery disease (CAD) before and after coronary artery bypass graft (CABG) surgery.

Secondary Outcome Measures

Name	Time	Method
Understanding correlation in HRV measurements taken immediately after surgery compared versus HRV measurements taken prior to hospital discharge.	Two HRV measurements taken for comparison; - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.	The secondary aim of this study would be to associate this change in HRV with the patient's clinical course to establish HRV as a way to assess current patient status and to predict clinical course and outcomes.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States