Actively Recruiting
LANdiolol to Avoid Tachycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-05
114
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the ultra-short acting beta-blocker landiolol to limit perioperative tachycardia in patients aged 45 and older who have cardiovascular risk factors and are undergoing major non-cardiac surgery. The study aims to see if controlling heart rate below 90 beats per minute during the perioperative period can reduce the risk of myocardial injury, a serious complication associated with increased mortality after surgery. This feasibility trial will help determine if this intervention can be safely and effectively applied before a larger trial is conducted. Participants will be randomly assigned to one of two groups. In the experimental group, landiolol will be given during surgery, with the dose adjusted between 1 to 40 mcg/kg/min to maintain a heart rate below 90 beats per minute, while ensuring mean arterial pressure stays above 65 mmHg. The control group will receive usual care, focusing on maintaining mean arterial pressure above 65 mmHg and addressing any causes of tachycardia such as low blood volume or pain. The intervention period spans from the induction of anesthesia until discharge from the postanesthetic care unit. During the study, participants will be closely monitored for heart rate, blood pressure, and use of vasopressors. Researchers will measure the percentage of time the heart rate remains within the target range, as well as secondary outcomes like length of stay in the postanesthetic care unit and hospital, total vasopressor dose, and incidence of perioperative myocardial injury within 72 hours after surgery. The study starts in April 2026 and will continue through March 2028, with safety and feasibility as key focuses throughout the trial.
CONDITIONS
Brief Title
LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective non-cardiac surgery classified as intermediate or high-risk by 2022 European Society of Cardiology guidelines
- Surgery performed under general anesthesia
- Expected hospital stay of 24 hours or more
- Age 45 years or older
- At least two of the following risk factors: age 75 or older, arterial hypertension, ischemic heart disease, history of congestive heart failure, history of cerebrovascular disease, peripheral artery disease, diabetes mellitus, reduced kidney function (GFR ≤ 59 ml/min/1.73 m2), or pre-operative NTproBNP > 200 pg/ml
- Evidence of excessive sympathetic outflow shown by exercise testing, such as impaired heart rate recovery (≤ 12 bpm within 1 minute after exercise) or exaggerated heart rate response (≥ 12 bpm after 3 minutes of unloaded pedaling)
You will not qualify if you...
- Inability to consent or follow study procedures
- Absolute contraindications for exercise testing
- Pregnancy or intention to become pregnant
- Active cardiac conditions like unstable coronary syndromes, decompensated heart failure, significant arrhythmias, or severe valvular disease
- Urgent or emergency surgery
- Current or recent use of beta-blockers within 30 days prior to recruitment
- Contraindications to beta-blocker therapy, including bradycardia (heart rate below 55 bpm), hypotension (systolic blood pressure below 100 mmHg), severe peripheral vascular disease, severe asthma, allergy, or higher-degree atrioventricular block
- Severe preoperative anemia (hemoglobin below 100 g/L) without planned correction prior to surgery
- Planned admission to intermediate or intensive care
- Previous participation in this trial
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From induction of anesthesia until discharge from postanesthetic care unit
Participants receive landiolol during surgery to maintain heart rate below 90 beats per minute and manage blood pressure, or receive usual care without beta-blocker intervention.
1 surgical visit and postanesthetic care unit stay
Duration - 72 hours after surgery
Participants are monitored for perioperative myocardial injury and recovery for 72 hours after surgery.
Follow-up assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Bern University Hospital, Freiburgstrasse
Bern, Switzerland, 3010
Actively Recruiting
Research Team
C
Christian M Beilstein, MD
P
Patrick Y Wuethrich, Prof MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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