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New treatment option for Perioperative Myocardial Injury
Official title LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery
ClinicalTrials.gov ID: NCT07168421
What this study is testing
What is Landiolol?
Landiolol is an investigational medicine, being studied as a potential treatment for perioperative myocardial injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join 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:
You likely can't join 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);
See the full eligibility 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...
- 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);
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.