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LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
RECRUITINGPhase 4Sponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
PhasePhase 4
SponsorInsel Gruppe AG, University Hospital Bern
Started2026-04-24
Est. completion2028-01-31
Eligibility
Age45 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07168421
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 cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.
Eligibility
Age: 45 Years+Healthy volunteers accepted
Inclusion Criteria: * Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines * surgery performed under general anesthesia; * expected length of hospital stay ≥ 24 hours; * age ≥ 45 years; * at least two of the following risk factors: * age ≥ 75 years * arterial hypertension; * 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; * peripheral artery disease; * diabetes mellitus; * GFR ≤ 59 ml/min pro 1.73 m2; * pre-operative NTproBNP \> 200 pg/ml; * excessive sympathetic outflow as proven by exercise testing: * impaired heart rate recovery (≤ 12 bpm within 1 minute after cessation of exercise); OR * exaggerated heart rate response (≥ 12 bpm after 3 minutes of unloaded pedalling); Exclusion Criteria: * 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.
Conditions7
Autonomic DysfunctionBeta-blockerCardiovascular (CV) RiskHeart DiseaseMajor SurgeryMyocardial Injury After Non-Cardiac SurgeryPerioperative Myocardial Injury
Interventions1
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Actively Recruiting
PhasePhase 4
SponsorInsel Gruppe AG, University Hospital Bern
Started2026-04-24
Est. completion2028-01-31
Eligibility
Age45 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07168421