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

NCT07168421 | Recruiting Phase 4

• 1 other identifier: BECD-1-21
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Perioperative Myocardial Injury; Autonomic Dysfunction; Cardiovascular (CV) Risk; Major Surgery; Beta Blocker; Myocardial Injury After Non-cardiac Surgery

Keywords

perioperative myocardial injury; major surgery; beta blocker; myocardial injury after non-cardiac surgery; autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• Time perioperative heart rate in target range

  As a marker of successful intervention, time perioperative heart rate in target range (below 90 beats per minute) will serve as primary outcome. The intervention is considered feasible if the heart rate stays at least 90% of the time within the target range during the perioperative period.

  From induction of anaesthesia until discharge from postanaesthetic care unit [percent of time heart rate within target range (<90 beats per minute)]

Secondary Outcomes (5)

• Perioperative heart rate

  From induction of anaesthesa until discharge from postanaesthetic care unit [heart rate in beats per minute * minutes ]

• Dose of vasopressors

  Induction of anaesthesia until discharge from postanaeshetic care unit [mcg per recorded drug]

• Length of postanaesthetic care unit stay

  Admission to postanaesthetic care unit until discharge from postanaesthetic care unit [minutes]

• Length of hospital stay

  Admission to hospital until discharge from hospital [days]

• Perioperative myocardial injury

  72 hours after surgery

Other Outcomes (4)

• Major adverse cardio- and cerebrovascular events

  30 days after surgery

• All-cause death

  30 days after surgery

• Quality of life (EQ-5D)

  30 days after surgery

Study Arms (2)

Landiolol

EXPERIMENTAL

Landiolol will be titrated to keep heart rate below 90 beats per minute during surgery after exclusion of other factors possibly causing tachycardia (such as hypovolaemia or pain). Mean arterial pressure will be kept above 65 millimeters of mercury.

Drug: Landiolol

Usual care

NO INTERVENTION

In the usual care group, mean arterial pressure will be maintained above 65 millimeters of mercury. In case of tachycardia, causing reasons (such as hypovolaemia) will be sought and treated.

Interventions

Landiolol DRUG

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.

Landiolol

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital, Freiburgstrasse

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Primary Dysautonomias

Interventions

landiolol

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Christian M Beilstein, MD

CONTACT

+41316644308; christian.beilstein@insel.ch

Patrick Y Wuethrich, Prof MD

CONTACT

+41316322483; patrick.wuethrich@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 11, 2025
• Study Start: April 24, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)