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Completed

NCT Number: NCT05561608

Validation of Heart Rate Recovery as a Peri-operative Risk Measure

Is heart rate recovery after submaximal exercise (i.e. not to exhaustion) a valid risk measure for post-operative outcomes?

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Golden Jubilee National Hospital, Clydebank, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: 1 week post-operatively

    As defined by KDIGO consensus

  2. Major adverse kidney events

    Time frame: 30 days post-operatively

    Composite of renal mortality, renal replacement therapy, over 30% decline in eGFR from baseline

  3. Cardiovascular complications

    Time frame: 7 days post-operatively

    Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation

  4. Major adverse cardiac events

    Time frame: 30 days post-operatively

    Composite of cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation

  5. Infective complications

    Time frame: 7 days post-operatively

    Presence of fever <38.5 and clinical suspicion of infection

  6. Neurological complications

    Time frame: 7 days post-operatively

    Delirium or stroke

  7. Pulmonary complications

    Time frame: 7 days post-operatively

    Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration

  8. Quality of recovery scale - 15

    Time frame: 2 days post-operatively

  9. EQ-5D-5L

    Time frame: 30 days and 1 year post-operatively

    Patient reported quality of life score

  10. Days alive and out of hospital

    Time frame: 30 days post-operatively

  11. Length of hospital stay (with/without hospital mortality)

    Time frame: Up to 1 year post-operatively

  12. Readmission to hospital

    Time frame: Within 30 days post-operatively

  13. Admission/re-admission to Intensive Care

    Time frame: 14 days post-operatively

  14. Mortality

    Time frame: Day 30, day 90 and 1 year post-operatively

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • NHS Ayrshire and Arran
  • NHS Greater Glasgow and Clyde
  • NHS Lanarkshire
  • NHS National Waiting Times Centre Board

Registry information

Official study title

Validation of Heart Rate Recovery as a Peri-operative Risk Measure (VERVE)

Acronym: VERVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 30, 2022
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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