Condition category
Surgery
Date applied
22/01/2018
Date assigned
23/01/2018
Last edited
22/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Major elective abdominal surgery carries a significant risk of mortality (death) and morbidity (illness), a proportion of which is directly due to specific cardiac disease, particularly heart failure. Before people have major surgery they undergo a simple test on a cycle machine, which helps to determine if there are likely to be any particular problems during or after the surgery. These results are used to plan the best way to look after patients around the time of their operation as part of their standard care. For a small number of patients the cycle exercise test shows that the heart function is not as good as expected, with these patients showing a higher risk of developing serious problems after surgery. The aim of this study is to see whether the heart function of surgical patients can be improved using a medication to improve heart function (bisoprolol), thus reducing the risk of mortality and morbidity for these patients.

Who can participate?
Patients aged 55 years or over who are scheduled for major abdominal surgery

What does the study involve?
Participants are prescribed bisoprolol to be taken daily. After 10 days at a follow up appointment their heart function is assessed.

What are the possible benefits and risks of participating?
Taking bisoprolol may improve the performance of the heart and by reduce the risks of having the operation. No additional risks are expected as bisoprolol is fully licensed for use in improving heart performance. There are additional assessments required for the study, which may extend a clinic visit.

Where is the study run from?
York Teaching Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2016 to February 2021

Who is funding the study?
Elsie May Sykes Charitable Research Fund (UK)

Who is the main contact?
Tracey Dorey
tracey.dorey@york.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Tracey Dorey

ORCID ID

Contact details

Research & Development
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0)1904 729654
tracey.dorey@york.nhs.uk

Additional identifiers

EudraCT number

2017-002443-15

ClinicalTrials.gov number

Protocol/serial number

3.0 (08/08/2017)

Study information

Scientific title

Improving cardiac function in high-risk surgical patients: exercise testing, biomarkers and beta-blockade

Acronym

ICAF-BETA

Study hypothesis

Administration of Bisoprolol to participants with impaired VE/VCO2 will improve cardiac function.

Ethics approval

Yorkshire & The Humber - Leeds West Research Ethics Committee, 25/08/2017, ref: 17/YH/0222

Study design

Prospective proof of concept case series

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Patients with impaired VE/VCO2 scheduled for major intra-abdominal surgery

Intervention

Patients aged 55 years or over, scheduled for major abdominal surgery will be eligible. These patients will be sent information about the study prior to their routine pre-assessment appointment. Those patients who consent will undergo screening as part of their appointment; if they meet all inclusion criteria they will be enrolled and prescribed Bisoprolol 2.5mg to be taken daily for a minimum of 7 days prior to surgery. After 10 days a follow up appointment will be required to review heart function.

Intervention type

Drug

Phase

Not Applicable

Drug names

Bisoprolol

Primary outcome measure

Ventilator equivalent for CO2 (VE/VCO2), measured at anaerobic threshold or nadir using CO2 output prior to surgery

Secondary outcome measures

1. Beta-natriuretic peptide, measured using blood test at baseline and 10 days post IMP commencement
2. Systolic and diastolic function, measured using ECG at baseline and 10 days post IMP commencement
3. Anaerobic threshold, measured using CPET at baseline and 10 days post IMP commencement
4. Myocardial abnormality (VO2/HR response, VO2/Watt response), measured using CPET at baseline and 10 days post IMP commencement

Overall trial start date

28/03/2016

Overall trial end date

01/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 55 years or over
2. Scheduled for major intra-abdominal surgery
3. Presenting for routine CPET as part of pre-assessment
4. Not currently taking any BB medication and not taken BB medication within 1 month prior
5. Consent to GP being informed
6. VE/VCO2 34 or greater on CPET, as either the value measured at VO2@AT, or the lowest measured value, plus at least one of the following:
6.1. Presence of a known history of a clinical risk factor for major adverse cardiac events (MACE) after surgery
6.1.1. Ischaemic heart disease
6.1.2. Cerebrovascular disease
6.1.3. Renal insufficiency (creatinine > 170 mol.L-1)
6.1.4. Chronic heart failure
6.2. Evidence of abnormal myocardial response on exercise testing
6.2.1. Flattened or inflecting oxygen uptake to heart rate response (oxygen pulse response, VO2/HR, panel 2)
6.2.2. Flattened or inflecting oxygen uptake to work rate response (VO2/Watt, panel 3)
6.3. Anaerobic threshold <11ml/kg/min

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. Refusal or unable to give informed consent
2. Fewer than 7 days before scheduled surgery at pre-assessment appointment surgery
3. Current beta blocker medication or having taken any beta blocker within 1 month prior
4. Contra-indications to BB medication including:
4.1. Bronchial asthma
4.2. Reversible airways disease
4.3. Decompensated heart failure (NYHA class IV)
4.4. Fluid overloaded
4.5. Hypotensive
4.6. Severe liver impairment
4.7. Second or third degree A-V block (unless pacemaker fitted)
4.8. SA block
4.9. Sick sinus syndrome (unless pacemaker inserted)
4.10. Cardiogenic shock
4.11. Bradycardia (heart rate less than 60 bpm)
4.12. Prinzmetal's angina
4.13. Untreated Phaeochromocytoma
4.14. Metabolic acidosis
4.15. Poor blood circulation in the hands and feet
4.16. Severe peripheral arterial insufficiency
4.17. Known hypersensitivity to bisoprolol or its ingredients (lactose monohydrate, silica colloidal anhydrous, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate)
4.18. Co-prescription with negative chronotropic agents such as digoxin, diltiazem, verapamil, amiodarone
4.19. Co-prescription with medications that affect the plasma concentrations of bisoprolol such as rifampin, cimetidine, quinidine, fluoxetine, paroxetine, propafenone, digoxin, reserpine, monoamine oxidase inhibitors, clonidine

Recruitment start date

01/02/2018

Recruitment end date

01/01/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO30 4SR
United Kingdom

Sponsor information

Organisation

York Teaching Hospital NHS Foundation Trust

Sponsor details

Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0)1904 725123
deborah.phillips@york.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Elsie May Sykes Charitable Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Details are not yet finalised but results will be published in appropriate journals.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes