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

NCT05561608 | Completed

• 1 other identifier: 21/WA/0207
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Peri-operative Injury

Keywords

Heart rate recovery; Submaximal exercise testing; Post-operative myocardial injury; Validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Acute Kidney Injury

  1 week post-operatively

• Major adverse kidney events

  30 days post-operatively

• Cardiovascular complications

  7 days post-operatively

• Major adverse cardiac events

  30 days post-operatively

• Infective complications

  7 days post-operatively

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• NHS National Waiting Times Centre Board: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• NHS Ayrshire and Arran: collaborator
• NHS Lanarkshire: collaborator

Study Sites (3)

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

University Hospital Hairmyres

East Kilbride, G75 8RG, United Kingdom

Location

University Hospital, Crosshouse

Kilmarnock, KA2 0BE, United Kingdom

Location

Study Officials

• Benjamin Shelley, MBChB, MD

  National Waiting Times Centre Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor/Consultant in Cardiothoracic Anaesthesia and Intensive Care

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: February 10, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GB (3)