Improving heart functioning in high-risk surgical patients

Phase 1

• Conditions: Impaired VE/CO2 on cardio pulmonary exercise testing; MedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002443-15-GB
• Lead Sponsor: York Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

- Aged 55 years or over
- Scheduled for major intra-abdominal surgery
- Presenting for routine CPET as part of pre-assessment
- Not currently taking any BB medication and not taken BB medication within 1 month prior
- Consent to GP being informed
- VE/VCO2 greater than 34 on CPET, as either the value measured at VO2@AT, or the lowest measured value, plus at least one of the following:
- Presence of a known history of a clinical risk factor for major adverse cardiac events (MACE) after surgery
?Ischaemic heart disease
?Cerebrovascular disease
?Renal insufficiency (creatinine > 170 ?mol.L-1)
?Chronic heart failure

- Evidence of abnormal myocardial response on exercise testing
- Flattened or inflecting oxygen uptake to heart rate response (oxygen pulse response, VO2/HR, panel 2)
- Flattened or inflecting oxygen uptake to work rate response (VO2/Watt, panel 3)
- Anaerobic threshold <11mls/kg/min

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

- Refusal or unable to give informed consent
- Fewer than 7 days before scheduled surgery at pre-assessment appointment surgery
- Current Beta blocker medication or having taken any Beta blocker within 1 month prior
- Contra-indications to BB medication including:
obronchial asthma
oreversible airways disease
odecompensated heart failure (NYHA class IV)
ofluid overloaded
ohypotensive
osevere liver impairment
osecond or third degree A-V block (unless pacemaker fitted)
oSA block
osick sinus syndrome (unless pacemaker inserted)
ocardiogenic shock
obradycardia (heart rate less than 60 bpm)
oPrinzmetal's angina
oUntreated Phaeochromocytoma
ometabolic acidosis
opoor blood circulation in the hands and feet
osevere peripheral arterial insufficiency
oknown hypersensitivity to bisoprolol or its ingredients (lactose monohydrate, silica colloidal anhydrous, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate)
oco-prescription with negative chronotropic agents such as digoxin, diltiazem, verapamil, amiodarone
oco-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study objective is to assess the effect of bisoprolol on heart function in high-risk surgical patients through assessment of exercise testing and a reduction in VE/VCO2;Secondary Objective: The secondary objectives are to assess the effect of bisoprolol on heart function in high-risk surgical patients through assessment of anaerobic threshold and evidence of heart abnormality. ;Primary end point(s): The effect on the ventilator equivalent for CO2 (VE/VCO2) as measured at anaerobic threshold or nadir, after introduction of beta-blockade;Timepoint(s) of evaluation of this end point: Evaluation of the primary end point can be made after the last patient has had their second measurement of their ventilator equivalent for CO2 (VE/VCO2)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): <br>1.Anaerobic threshold pre- and post-bisoprolol<br>2.Evidence of myocardial abnormality on CPET (VO2/HR response, VO2/Watt response) pre- and post-bisoprolol<br>;Timepoint(s) of evaluation of this end point: Evaluation of the secondary end points can be made after the last patient has had their second measurement of the above measures.