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

Not Applicable

• Conditions: Patients with impaired VE/VCO2 scheduled for major intra-abdominal surgery; Surgery

• Registration Number: ISRCTN95679074
• Lead Sponsor: York Teaching Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-23
• Last Update Posted: 17 June 2019
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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