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

York Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 44 人开始时间: 2017年9月1日最近更新: 2020年7月27日

试验速览

暂无简介。

•- 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

•- 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)
•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

发起方

York Teaching Hospitals NHS Foundation Trust