Clinical trial NCT05561608: Validation of Heart Rate Recovery as a Peri-operative Risk Measure
Official title: Validation of Heart Rate Recovery as a Peri-operative Risk Measure (VERVE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peri-operative Injury
Keywords: Heart rate recovery
Submaximal exercise testing
Post-operative myocardial injury
Validation
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS National Waiting Times Centre Board
name: NHS Greater Glasgow and Clyde
name: NHS Ayrshire and Arran
name: NHS Lanarkshire
First posted: 2022-09-30
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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. We 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.

Our 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative myocardial injury
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Acute Kidney Injury
timeFrame: 1 week post-operatively
measure: Major adverse kidney events
timeFrame: 30 days post-operatively
measure: Cardiovascular complications
timeFrame: 7 days post-operatively
measure: Major adverse cardiac events
timeFrame: 30 days post-operatively
measure: Infective complications
timeFrame: 7 days post-operatively
measure: Neurological complications
timeFrame: 7 days post-operatively
measure: Pulmonary complications
timeFrame: 7 days post-operatively
measure: Quality of recovery scale - 15
timeFrame: 2 days post-operatively
measure: EQ-5D-5L
timeFrame: 30 days and 1 year post-operatively
measure: Days alive and out of hospital
timeFrame: 30 days post-operatively
measure: Length of hospital stay (with/without hospital mortality)
timeFrame: Up to 1 year post-operatively
measure: Readmission to hospital
timeFrame: Within 30 days post-operatively
measure: Admission/re-admission to Intensive Care
timeFrame: 14 days post-operatively
measure: Mortality
timeFrame: Day 30, day 90 and 1 year post-operatively
Other outcomes:
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: East Kilbride
country: United Kingdom
facility: University Hospital Hairmyres
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Kilmarnock
country: United Kingdom
facility: University Hospital, Crosshouse
Study officials:
affiliation: National Waiting Times Centre Board
name: Benjamin Shelley, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References: