Landiolol to prevent fast heart rates during major non-cardiac surgery in patients with cardiovascular risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 intervention uses continuous perioperative administration of the highly cardioselective, ultra‑short acting beta‑blocker landiolol to limit tachycardia (target heart rate <90 bpm) in patients at cardiovascular risk undergoing elective intermediate‑ or high‑risk non‑cardiac surgery under general anesthesia. Eligible participants are adults ≥45 years with at least two cardiovascular risk factors and evidence of excessive sympathetic outflow on exercise testing (impaired heart rate recovery or exaggerated heart rate response). The primary goal is to demonstrate feasibility of maintaining the heart rate target without causing hypotension or other safety issues, as a precursor to a larger efficacy trial measuring perioperative myocardial injury. The intervention is delivered perioperatively at Bern University Hospital with close hemodynamic monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bern University Hospital, Freiburgstrasse
  Bern, Switzerland Recruiting

Study contacts

• Study coordinator: Christian M Beilstein, MD
• Email: christian.beilstein@insel.ch
• Phone: +41316644308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.