EUCTR2017-002443-15-GB
Active, not recruiting
Phase 1
Improving cardiac function in high-risk surgical patients: exercise testing, biomarkers and beta-blockade - ICAF - BETA
York Teaching Hospitals NHS Foundation Trust0 sites44 target enrollmentSeptember 1, 2017
DrugsBisoprolol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- York Teaching Hospitals NHS Foundation Trust
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\)
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
Outcomes
Primary Outcomes
Not specified
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