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

Peri-operative Injury Clinical Trial

— VERVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561608
• Other study ID #: 21/WA/0207
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: February 2024

Study information

• Verified date: September 2022
• Source: University of Glasgow
• Contact: Cara Hughes, BM, MSc
• Phone: 0141 951 5000
• Email: cara.hughes[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: February 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-operative Injury

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	University Hospital Hairmyres	East Kilbride
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	University Hospital, Crosshouse	Kilmarnock

Sponsors (5)

Lead Sponsor	Collaborator
University of Glasgow	NHS Ayrshire and Arran, NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS National Waiting Times Centre Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative myocardial injury	Post-operative troponin over the 99th centile upper reference limit plus a 20% change (increase or decrease)	48 hours post-operatively
Secondary	Acute Kidney Injury	As defined by KDIGO consensus	1 week post-operatively
Secondary	Major adverse kidney events	Composite of renal mortality, renal replacement therapy, over 30% decline in eGFR from baseline	30 days post-operatively
Secondary	Cardiovascular complications	Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation	7 days post-operatively
Secondary	Major adverse cardiac events	Composite of cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation	30 days post-operatively
Secondary	Infective complications	Presence of fever <38.5 and clinical suspicion of infection	7 days post-operatively
Secondary	Neurological complications	Delirium or stroke	7 days post-operatively
Secondary	Pulmonary complications	Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration	7 days post-operatively
Secondary	Quality of recovery scale - 15		2 days post-operatively
Secondary	EQ-5D-5L	Patient reported quality of life score	30 days and 1 year post-operatively
Secondary	Days alive and out of hospital		30 days post-operatively
Secondary	Length of hospital stay (with/without hospital mortality)		Up to 1 year post-operatively
Secondary	Readmission to hospital		Within 30 days post-operatively
Secondary	Admission/re-admission to Intensive Care		14 days post-operatively
Secondary	Mortality		Day 30, day 90 and 1 year post-operatively