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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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);

Locations
Other Locations
Switzerland
Bern University Hospital, Freiburgstrasse
RECRUITING
Bern
Contact Information
Primary
Christian M Beilstein, MD
christian.beilstein@insel.ch
+41316644308
Backup
Patrick Y Wuethrich, Prof MD
patrick.wuethrich@insel.ch
+41316322483
Time Frame
Start Date: 2026-04-24
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 114
Treatments
Experimental: Landiolol
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.
No_intervention: Usual care
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.
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov