Perioperative Myocardial InjuryPhase 4LANTA-PNCT07168421
LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
A Phase 4 study testing Landiolol in people with Perioperative Myocardial Injury and Autonomic Dysfunction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Perioperative Myocardial Injury, Autonomic Dysfunction, Cardiovascular (CV) Risk
- What is being tested?
- Landiolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Apr 2026to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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);
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bern University Hospital, Freiburgstrasse
Bern, 3010
Christian M Beilstein, PD Dr. med., +41316644308, Christian.Beilstein@insel.ch
Patrick Y Wuethrich, Prof. Dr. med., +41316322483, patrick.wuethrich@insel.ch
About this study
Official title: LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial
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.
Read the detailed description
Despite advances in surgical and anaesthetic techniques, perioperative mortality remains high, even in developed countries. Major complications contributing almost half of all deaths after surgery are major bleeding (17%), myocardial injury after non-cardiac surgery (13%) and sepsis (12%). Myocardial injury after non-cardiac surgery occurs up to 18% in patients >45 years and is associated with a marked increase in 30-day mortality. Additional factors posing patients at risk for perioperative myocardial injury might be autonomic dysfunction, measured as exaggerated heart rate response to exercise or impaired heart rate recovery thereafter, as perioperative tachycardia is associated with perioperative myocaridal injury. The perioperative use of beta-blockers remains controversial, but the newely marketed ultra-short acting and highly cardioselective beta-blocker landiolol offers the opportunity to reduce perioperative heart rate without affecting blood pressure. The intervention (perioperative reduction of heart rate using landiolol) in this specific patient population needs to be proven as feasible prior to conducting a larger scale trial.
- Conditions
- Perioperative Myocardial Injury, Autonomic Dysfunction, Cardiovascular (CV) Risk, Major Surgery, Beta Blocker, Myocardial Injury After Non-cardiac Surgery
- Being tested
- Landiolol
- Keywords
- perioperative myocardial injury, major surgery, beta blocker, myocardial injury after non-cardiac surgery, autonomic dysfunction
- Medical subject headings
- Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LandiololDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Perioprative heart rate will be calculated as time weighted area under the curve for the perioperative period.
Measured: From induction of anaesthesa until discharge from postanaesthetic care unit [heart rate in beats per minute * minutes ]
Dose of vasopressors
Total dose of vasopressors such as noradrenalin, ephedrine or phenylephrine will be recorded in micrograms.
Measured: Induction of anaesthesia until discharge from postanaeshetic care unit [mcg per recorded drug]
Length of postanaesthetic care unit stay
Lenght of postaenaesthetic care unit stay will be recorded in minutes.
Measured: Admission to postanaesthetic care unit until discharge from postanaesthetic care unit [minutes]
Length of hospital stay
Length of hospital stay will be recorded in days.
Measured: Admission to hospital until discharge from hospital [days]
Perioperative myocardial injury
Perioperative myocardial injury (PMI) is defined as an increase of hsTroponinT ≥ 14ng/L above the preoperative value according to the Basel-PMI criteria, not meeting major adverse cardiovascular event (MACE) criteria.
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start24 Apr 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168421
- Sponsor's protocol ID
- BECD-1-21
- Acronym
- LANTA-P
- Status last verified
- May 2026
- First submitted
- 11 Aug 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be provided on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT07168421
- Acronym / sponsor ID
- LANTA-P / BECD-1-21
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite advances in surgical and anaesthetic techniques, perioperative mortality remains high, even in developed countries. Major complications contributing almost half of all deaths after surgery are major bleeding (17%), myocardial injury after non-cardiac surgery (13%) and sepsis (12%). Myocardial injury after non-cardiac surgery occurs up to 18% in patients >45 years and is associated with a marked increase in 30-day mortality. Additional factors posing patients at risk for perioperative myocardial injury might be autonomic dysfunction, measured as exaggerated heart rate response to exercise or impaired heart rate recovery thereafter, as perioperative tachycardia is associated with perioperative myocaridal injury. The perioperative use of beta-blockers remains controversial, but the newely marketed ultra-short acting and highly cardioselective beta-blocker landiolol offers the opportunity to reduce perioperative heart rate without affecting blood pressure. The intervention (perioperative reduction of heart rate using landiolol) in this specific patient population needs to be proven as feasible prior to conducting a larger scale trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landiolol | Experimental | Drug: LandiololLandiolol 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. |
| 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LandiololThe 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. | Drug | Landiolol |
Primary outcome
Time perioperative heart rate in target range
Time frame: From induction of anaesthesia until discharge from postanaesthetic care unit [percent of time heart rate within target range (<90 beats per minute)]
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.
5 secondary outcomes
Perioperative heart rate
Time frame: From induction of anaesthesa until discharge from postanaesthetic care unit [heart rate in beats per minute * minutes ]
Dose of vasopressors
Time frame: Induction of anaesthesia until discharge from postanaeshetic care unit [mcg per recorded drug]
Length of postanaesthetic care unit stay
Time frame: Admission to postanaesthetic care unit until discharge from postanaesthetic care unit [minutes]
Length of hospital stay
Time frame: Admission to hospital until discharge from hospital [days]
Perioperative myocardial injury
Time frame: 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. IPD can be provided on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Landiolol in people with Perioperative Myocardial Injury and Autonomic Dysfunction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian M Beilstein, MD (+41316644308, christian.beilstein@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time perioperative heart rate in target range (time frame: From induction of anaesthesia until discharge from postanaesthetic care unit [percent of time heart rate within target range (<90 beats per minute)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.