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

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?

Study Overview

• Status: Recruiting
• Conditions: Peri-operative Injury

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.

• Study Type: Observational
• Enrollment (Anticipated): 95

Contacts and Locations

• Study Contact: Name: Cara Hughes, BM, MSc; Phone Number: 0141 951 5000; Email: cara.hughes@glasgow.ac.uk
• Study Contact Backup: Name: Benjamin Shelley, MBChB, MD; Phone Number: 0141 951 5000; Email: Benjamin.Shelley@glasgow.ac.uk

Study Locations

• United Kingdom
  • Clydebank, United Kingdom
    • Not yet recruiting
    • Golden Jubilee National Hospital
    • Contact: Ben Shelley, MD; Phone Number: 4293 0141 9515000; Email: b.shelley@clinmed.gla.ac.uk
    • Principal Investigator: Ben Shelley, MD
    • Principal Investigator: Cara Hughes, BM,MSc
  • East Kilbride, United Kingdom, G75 8RG
    • Recruiting
    • University Hospital Hairmyres
    • Contact: Tina McLennan, MBChB
    • Principal Investigator: Tina McLennan, MBChB
  • Glasgow, United Kingdom, G51 4TF
    • Not yet recruiting
    • Queen Elizabeth University Hospital
    • Contact: Malcolm Watson, PhD
    • Principal Investigator: Malcolm Watson, PhD
  • Kilmarnock, United Kingdom, KA2 0BE
    • Not yet recruiting
    • University Hospital, Crosshouse
    • Contact: Andrew Clark
    • Principal Investigator: Andrew Clark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury	As defined by KDIGO consensus	1 week post-operatively
Major adverse kidney events	Composite of renal mortality, renal replacement therapy, over 30% decline in eGFR from baseline	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	7 days post-operatively
Major adverse cardiac events	Composite of cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation	30 days post-operatively
Infective complications	Presence of fever <38.5 and clinical suspicion of infection	7 days post-operatively
Neurological complications	Delirium or stroke	7 days post-operatively
Pulmonary complications	Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration	7 days post-operatively
Quality of recovery scale - 15		2 days post-operatively
EQ-5D-5L	Patient reported quality of life score	30 days and 1 year post-operatively
Days alive and out of hospital		30 days post-operatively
Length of hospital stay (with/without hospital mortality)		Up to 1 year post-operatively
Readmission to hospital		Within 30 days post-operatively
Admission/re-admission to Intensive Care		14 days post-operatively
Mortality		Day 30, day 90 and 1 year post-operatively

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: NHS Greater Glasgow and Clyde; NHS National Waiting Times Centre Board; NHS Lanarkshire; NHS Ayrshire and Arran
• Investigators: Principal Investigator: Benjamin Shelley, MBChB, MD, National Waiting Times Centre Board

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Validation; Heart rate recovery; Submaximal exercise testing; Post-operative myocardial injury
• Other Study ID Numbers: 21/WA/0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No