Status:
NOT_YET_RECRUITING
LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Perioperative Myocardial Injury
Autonomic Dysfunction
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascul...
Detailed Description
Despite advances in surgical and anaesthetic techniques, perioperative mortality remains high, even in developed countries. Major complications contributing almost half of all deaths after surgery are...
Eligibility Criteria
Inclusion
- Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines
- expected duration of surgery of at least 90 minutes;
- expected length of hospital stay ≥ 24 hours;
- age \> 45 years with at least two of the following risk factors (adapted from revised cardiac risk index):
- ischemic heart disease (history of myocardial infarction or positive exercise test, current complaint of chest pain considered to be secondary to myocardial ischemia, use of nitrates, pathological Q waves, prior coronary revascularization);
- history of congestive heart failure;
- history of cerebrovascular disease;
- insulin-dependent diabetes mellitus;
- creatinine \> 176.8 mmol/l;
- pre-operative NTproBNP \> 200 pg/ml;
- excessive sympathetic outflow as proven by exercise testing:
- impaired HR recovery (≤ 12 bpm within 1 minute after cessation of exercise); OR
- exaggerated HR response (≥ 12 bpm after 1 minute of unloaded pedalling);
Exclusion
- unable to consent or follow study procedures;
- absolute contraindications for exercise testing;
- pregnancy or intention to become pregnant;
- active cardiac conditions (such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease);
- urgent / emergency surgery;
- already on β-blocker (within the last 30 days prior to recruitment);
- contraindication for β-blocker therapy (bradycardia (HR \< 55 bpm), hypotension (systolic blood pressure \< 100 mmHg), severe peripheral vascular disease, severe asthma, allergy, higher-degree atrioventricular block);
- severe preoperative anaemia (haemoglobin \< 100 g/L) unless there is a plan set up and followed for correction prior to surgery;
- planned intermediate care or intensive care admission;
- prior enrolment in this trial.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT07168421
Start Date
October 1 2025
End Date
March 1 2028
Last Update
September 11 2025
Active Locations (1)
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1
Bern University Hospital, Freiburgstrasse
Bern, Switzerland, 3010