Peri-operative InjuryVERVENCT05561608
Validation of Heart Rate Recovery as a Peri-operative Risk Measure
An observational study of Peri-operative Injury, run by University of Glasgow at 3 sites in United Kingdom.
Trial summary
Is heart rate recovery after submaximal exercise (i.e. not to exhaustion) a valid risk measure for post-operative outcomes? Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peri-operative Injury
- How many people
- 84 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 10 Feb 2022to 1 Aug 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 95 patients 50 years or over undergoing intermediate/high risk surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, University Hospital Hairmyres or University Hospital Crosshouse.
Who may be able to join
- Provision of informed consent
- Age 50 years or over
- Able to walk unaided
- Planned elective intermediate/high risk surgery as defined by the ESC/ESA guidelines (i.e. >1% risk of mortality)
Who cannot join
- Pregnancy
- Ongoing participation in any investigational research which could undermine the scientific basis of the study
- Presence of any of the American Thoracic Society's contraindications to exercise testing
- Previous intermediate/high risk surgery within three months prior to recruitment
- Previous participation in the VERVE study at any time
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Golden Jubilee National Hospital
Clydebank
University Hospital Hairmyres
East Kilbride, G75 8RG
University Hospital, Crosshouse
Kilmarnock, KA2 0BE
About this study
Official title: Validation of Heart Rate Recovery as a Peri-operative Risk Measure (VERVE)
Is heart rate recovery after submaximal exercise (i.e. not to exhaustion) a valid risk measure for post-operative outcomes?
Read the detailed description
There are approximately 1.5 million major operations carried out in the NHS every year. As the population ages, and surgical technique becomes more advanced, more patients are undergoing operations which carry a high risk of complications. Currently, doctors predict this risk by asking patients about medical problems and their level of physical fitness. If an operation is very high risk, a patient may undergo cardiopulmonary exercise testing (CPET) where the patient rides an exercise bike to maximum effort (exhaustion) whilst their heart and lung function is measured. This gives the doctor specific numbers which can be discussed with the patient about the risk of complications after surgery. However, CPET is expensive and not all patients are able to do it, for example due to joint or circulation problems. Patients can also find attempting to reach maximal effort demanding and uncomfortable.
Heart rate recovery (HRR) after maximal exercise has been shown to indicate post-operative risk of complications, and is also related to life-expectancy in people with heart failure. The utility of HRR after submaximal exercise however has not been investigated as extensively. One group demonstrated that submaximal HRR predicts post-operative complications after lung surgery, and submaximal HRR also predicts life-expectancy in healthy individuals. There is less information about submaximal HRR as the methods of measuring it are not standardised. Previous work by our group has confirmed the reproducibility of submaximal HRR in a healthy population, and demonstrated different ways in which to measure it. The investigators believe that submaximal HRR provides a "middle-ground" method of assessing how fit a patient is for surgery.
With informed consent, 95 patients across four hospitals in the West of Scotland will perform a step test pre-operatively. The step test will involve non-invasive measurement of the heart rate. Patients will exercise until approximately two-thirds of their predicted maximum heart rate is reached and then recover sitting, whilst the rate of their heart rate recovery is recorded. Patients will have pre- and post-operative troponin values measured (blood marker of strain/injury to the heart). Alongside the blood tests, patients will also answer questionnaires related to their quality of life, and information regarding other post-operative complications will be recorded.
The study aims to demonstrate that submaximal HRR is predictive of post-operative myocardial injury (stress/injury to the heart wall due to the body's response to the operation) and that is it a valid measure when compared to the scores, blood tests and exercise tests that are currently in use in the NHS. In the future, submaximal exercise testing with HRR measurement may be offered to patients unable to perform CPET and will guide shared decision-making between patient, surgeon and anaesthetist to ensure the best outcome for the patient regarding their surgical options.
- Conditions
- Peri-operative Injury
- Keywords
- Heart rate recovery, Submaximal exercise testing, Post-operative myocardial injury, Validation
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative myocardial injury
Post-operative troponin over the 99th centile upper reference limit plus a 20% change (increase or decrease)
Measured: 48 hours post-operatively
Secondary outcomes (14)
Acute Kidney Injury
As defined by KDIGO consensus
Measured: 1 week post-operatively
Major adverse kidney events
Composite of renal mortality, renal replacement therapy, over 30% decline in eGFR from baseline
Measured: 30 days post-operatively
Cardiovascular complications
Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation
Measured: 7 days post-operatively
Major adverse cardiac events
Composite of cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation
Measured: 30 days post-operatively
Infective complications
Presence of fever <38.5 and clinical suspicion of infection
Measured: 7 days post-operatively
Neurological complications
Delirium or stroke
Measured: 7 days post-operatively
Pulmonary complications
Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration
Measured: 7 days post-operatively
Quality of recovery scale - 15
Measured: 2 days post-operatively
EQ-5D-5L
Patient reported quality of life score
Measured: 30 days and 1 year post-operatively
Days alive and out of hospital
Measured: 30 days post-operatively
Length of hospital stay (with/without hospital mortality)
Measured: Up to 1 year post-operatively
Readmission to hospital
Measured: Within 30 days post-operatively
Admission/re-admission to Intensive Care
Measured: 14 days post-operatively
Mortality
Measured: Day 30, day 90 and 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start10 Feb 2022
- Primary completion1 Jun 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS National Waiting Times Centre Board, NHS Greater Glasgow and Clyde, NHS Ayrshire and Arran, NHS Lanarkshire
- Responsible party
- Principal investigator, Dr Ben Shelley, University of Glasgow
- Investigators
- Benjamin Shelley, MBChB, MD, Principal investigator, National Waiting Times Centre Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561608
- Sponsor's protocol ID
- 21/WA/0207
- Acronym
- VERVE
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are keen to provide opportunities for data sharing. All requests for data sharing will be assessed individually and requests complying with the data governance regulations of the Sponsor and NHS R\&D will be honoured.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Heart Rate Recovery as a Peri-operative Risk Measure (VERVE)
- ClinicalTrials.gov ID
- NCT05561608
- Acronym / sponsor ID
- VERVE / 21/WA/0207
- Conditions
- Peri-operative Injury
- Keywords
- Heart rate recovery, Submaximal exercise testing, Post-operative myocardial injury, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS National Waiting Times Centre Board, NHS Greater Glasgow and Clyde, NHS Ayrshire and Arran, NHS Lanarkshire
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Sep 2022 (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.
Is heart rate recovery after submaximal exercise (i.e. not to exhaustion) a valid risk measure for post-operative outcomes?
Detailed description
There are approximately 1.5 million major operations carried out in the NHS every year. As the population ages, and surgical technique becomes more advanced, more patients are undergoing operations which carry a high risk of complications. Currently, doctors predict this risk by asking patients about medical problems and their level of physical fitness. If an operation is very high risk, a patient may undergo cardiopulmonary exercise testing (CPET) where the patient rides an exercise bike to maximum effort (exhaustion) whilst their heart and lung function is measured. This gives the doctor specific numbers which can be discussed with the patient about the risk of complications after surgery. However, CPET is expensive and not all patients are able to do it, for example due to joint or circulation problems. Patients can also find attempting to reach maximal effort demanding and uncomfortable.
Heart rate recovery (HRR) after maximal exercise has been shown to indicate post-operative risk of complications, and is also related to life-expectancy in people with heart failure. The utility of HRR after submaximal exercise however has not been investigated as extensively. One group demonstrated that submaximal HRR predicts post-operative complications after lung surgery, and submaximal HRR also predicts life-expectancy in healthy individuals. There is less information about submaximal HRR as the methods of measuring it are not standardised. Previous work by our group has confirmed the reproducibility of submaximal HRR in a healthy population, and demonstrated different ways in which to measure it. The investigators believe that submaximal HRR provides a "middle-ground" method of assessing how fit a patient is for surgery.
With informed consent, 95 patients across four hospitals in the West of Scotland will perform a step test pre-operatively. The step test will involve non-invasive measurement of the heart rate. Patients will exercise until approximately two-thirds of their predicted maximum heart rate is reached and then recover sitting, whilst the rate of their heart rate recovery is recorded. Patients will have pre- and post-operative troponin values measured (blood marker of strain/injury to the heart). Alongside the blood tests, patients will also answer questionnaires related to their quality of life, and information regarding other post-operative complications will be recorded.
The study aims to demonstrate that submaximal HRR is predictive of post-operative myocardial injury (stress/injury to the heart wall due to the body's response to the operation) and that is it a valid measure when compared to the scores, blood tests and exercise tests that are currently in use in the NHS. In the future, submaximal exercise testing with HRR measurement may be offered to patients unable to perform CPET and will guide shared decision-making between patient, surgeon and anaesthetist to ensure the best outcome for the patient regarding their surgical options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 95 patients 50 years or over undergoing intermediate/high risk surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, University Hospital Hairmyres or University Hospital Crosshouse.
Key inclusion criteria (4 listed)
- Provision of informed consent
- Age 50 years or over
- Able to walk unaided
- Planned elective intermediate/high risk surgery as defined by the ESC/ESA guidelines (i.e. >1% risk of mortality)
Key exclusion criteria (5 listed)
- Pregnancy
- Ongoing participation in any investigational research which could undermine the scientific basis of the study
- Presence of any of the American Thoracic Society's contraindications to exercise testing
- Previous intermediate/high risk surgery within three months prior to recruitment
- Previous participation in the VERVE study at any time
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
Post-operative myocardial injury
Time frame: 48 hours post-operatively
Post-operative troponin over the 99th centile upper reference limit plus a 20% change (increase or decrease)
14 secondary outcomes
Acute Kidney Injury
Time frame: 1 week post-operatively
Major adverse kidney events
Time frame: 30 days post-operatively
Cardiovascular complications
Time frame: 7 days post-operatively
Major adverse cardiac events
Time frame: 30 days post-operatively
Infective complications
Time frame: 7 days post-operatively
Neurological complications
Time frame: 7 days post-operatively
Pulmonary complications
Time frame: 7 days post-operatively
Quality of recovery scale - 15
Time frame: 2 days post-operatively
EQ-5D-5L
Time frame: 30 days and 1 year post-operatively
Days alive and out of hospital
Time frame: 30 days post-operatively
Length of hospital stay (with/without hospital mortality)
Time frame: Up to 1 year post-operatively
Readmission to hospital
Time frame: Within 30 days post-operatively
Admission/re-admission to Intensive Care
Time frame: 14 days post-operatively
Mortality
Time frame: Day 30, day 90 and 1 year post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. We are keen to provide opportunities for data sharing. All requests for data sharing will be assessed individually and requests complying with the data governance regulations of the Sponsor and NHS R\&D will be honoured.
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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.
Benjamin Shelley, MBChB, MD principal investigator
National Waiting Times Centre Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-operative Injury, run by University of Glasgow at 3 sites in United Kingdom.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 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 3 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative myocardial injury (time frame: 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2025.