NCT07168421 LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
| NCT ID | NCT07168421 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Perioperative Myocardial Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 114 participants in total. It began in 2026-04-24 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168421 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Perioperative Myocardial Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07168421 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07168421 currently recruiting?
Yes, NCT07168421 is actively recruiting participants. Contact the research team at christian.beilstein@insel.ch for enrollment information.
Where is the NCT07168421 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07168421 clinical trial?
NCT07168421 is sponsored by Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 114 participants.