Improving heart functioning in high-risk surgical patients

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002443-15-GB

Enrollment

Registered

2017-09-01

Start date

2017-09-20

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired VE/CO2 on cardio pulmonary exercise testing MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849

Interventions

Trade Name: Bisoprolol Product Name: Bisoprolol Pharmaceutical Form: Coated tablet INN or Proposed INN: Bisoprolol Fumarate CAS Number: 66722-44-9 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 34

Exclusion criteria

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: o bronchial asthma o reversible airways disease o decompensated heart failure (NYHA class IV) o fluid overloaded o hypotensive o severe liver impairment o second or third degree A-V block (unless pacemaker fitted) o SA block o sick sinus syndrome (unless pacemaker inserted) o cardiogenic shock o bradycardia (heart rate less than 60 bpm) o Prinzmetal's angina o Untreated Phaeochromocytoma o metabolic acidosis o poor blood circulation in the hands and feet o severe peripheral arterial insufficiency o known hypersensitivity to bisoprolol or its ingredients (lactose monohydrate, silica colloidal anhydrous, crospovidone (Type A), crospovidone (Type B), povidone 30, sucrose, magnesium stearate) o co-prescription with negative chronotropic agents such as digoxin, diltiazem, verapamil, amiodarone o 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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): 1. Anaerobic threshold pre- and post-bisoprolol 2. Evidence of myocardial abnormality on CPET (VO2/HR response, VO2/Watt response) pre- and post-bisoprolol ;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.	—

Countries

United Kingdom

Contacts

Public ContactMs Mia Porteous

York Teaching Hospital NHS Foundation Trust

mia.porteous@york.nhs.uk01904725129

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026