Coronary Artery DiseaseNCT07097168
Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery
An observational study of Coronary Artery Disease, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 11 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants for validation will come from the general population and will be allowed to come forward to the study team to express interest. Study team members will place flyers in public areas (e.g., waiting rooms) throughout the Tufts Medical Center campus. Flyers will contain contact information of the study team as well as a QR Code to a screening form for participants to fill out if they are interested in participating.
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Clinical Course in Coronary Artery Bypass Patients Using the WHOOP Fitness Band Heart Rate Variability Application.
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?
Read more
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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft, CABG, Heart Surgery, Heart Disease, Coronary Artery Disease, WHOOP, HRV, Heart Rate Variability
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability (HRV) Before and After CABG Surgery
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.
Measured: - 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.
Secondary outcomes (1)
Understanding correlation in HRV measurements taken immediately after surgery compared versus HRV measurements taken prior to hospital 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.
Measured: Two HRV measurements taken for comparison; - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start11 Jun 2025 (estimated)
- Primary completion11 Jan 2026 (estimated)
- Study completion11 Mar 2026 (estimated)
Why it stopped: Changes to study staffing and lack of coordinator support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick C Cobey, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097168
- Sponsor's protocol ID
- STUDY00004109
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all collected IPD, including demographic information, clinical measurements, and outcomes data (e.g., heart rate variability, recovery progress, and post-surgery health status). This data will be available for researchers who request it, in accordance with a data-sharing agreement.
Publications
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.
PubMed 34065516Tiwari 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.
PubMed 33390146Lakusic 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.
PubMed 19936115Van 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.
PubMed 35535246Evrengul 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.
PubMed 16630090Miller 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.
PubMed 36016077Dimeling 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.
PubMed 33941604Cromwell 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.
PubMed 2404169Malakar 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.
PubMed 30790284
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Clinical Course in Coronary Artery Bypass Patients Using the WHOOP Fitness Band Heart Rate Variability Application.
- ClinicalTrials.gov ID
- NCT07097168
- Acronym / sponsor ID
- STUDY00004109
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft, CABG, Heart Surgery, Heart Disease, Coronary Artery Disease, WHOOP, HRV, Heart Rate Variability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changes to study staffing and lack of coordinator support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 11 Jan 2026 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for validation will come from the general population and will be allowed to come forward to the study team to express interest. Study team members will place flyers in public areas (e.g., waiting rooms) throughout the Tufts Medical Center campus. Flyers will contain contact information of the study team as well as a QR Code to a screening form for participants to fill out if they are interested in participating.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Heart Rate Variability (HRV) Before and After CABG Surgery
Time frame: - 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.
1 secondary outcome
Understanding correlation in HRV measurements taken immediately after surgery compared versus HRV measurements taken prior to hospital discharge.
Time frame: Two HRV measurements taken for comparison; - Post-operative, Up to 1 day after surgery - 3 days prior to ICU discharge.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 34065516Bellenger 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.
- Background: PubMed 33390146Tiwari 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.
- Background: PubMed 19936115Lakusic 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.
- Background: PubMed 35535246Van 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.
- Background: PubMed 16630090Evrengul 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.
- Background: PubMed 36016077Miller 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.
- Background: PubMed 33941604Dimeling 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.
- Background: PubMed 2404169Cromwell 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.
- Background: PubMed 30790284Malakar 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.
- Individual participant dataSharing planned: Yes. We plan to share all collected IPD, including demographic information, clinical measurements, and outcomes data (e.g., heart rate variability, recovery progress, and post-surgery health status). This data will be available for researchers who request it, in accordance with a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick C Cobey, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) Before and After CABG Surgery (time frame: - 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07097168, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.