RecruitingPhase 4NCT07168421

LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery

LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

114 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria17

  • 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 Criteria10

  • 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.

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Interventions

DRUGLandiolol

The main dose range is 1-40 mcg/kg/min, titrated to the effect on heart rate aiming for a heart rate of below 90 beats per minute throughout. This dose can be decreased to 0 if heart rate stays below target.


Locations(1)

Bern University Hospital, Freiburgstrasse

Bern, Switzerland

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NCT07168421


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