GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery (NCT06324461) | Clinical Trial Compass
RecruitingPhase 4
GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery
China372 participantsStarted 2024-03-20
Plain-language summary
This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days prior to surgery or receive routine care.
Dulaglutide (Trulicity; Eli Lilly, USA) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Planned elective intermediate to high risk non-cardiac surgery
* Anticipated to remain hospitalized for at least one night after surgery
* Voluntarily agrees to participate by providing written informed consent
Exclusion Criteria:
* History of symptomatic hypoglycemia within 1 month of recruitment
* History of pancreatitis
* Diabetic retinopathy
* Personal or family history of medullary thyroid carcinoma (MTC)
* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* Acute coronary syndrome, decompensated heart failure, cardiogenic shock, or myocarditis within 1 month of recruitment
* Stroke or transient ischemic attack within 1 month of recruitment
* Known severe liver disease (Child-Pugh B or C)
* Stage 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) by Modified Diet in Renal Disease (MDRD) equation \< 15 mL/min)
* Recent use of GLP-1 RA within 1 month of recruitment
* Known allergy or hypersensitivity to GLP-1 RA
* Women of childbearing age who are not taking effective contraception, or who are pregnant or breast-feeding
* Use of Dipeptidyl peptidase-4 inhibitor(DPP4i)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a GLP-1 receptor agonist — a type of drug already used for diabetes and weight loss — to prevent heart muscle injury after non-cardiac surgery. Could this approach be relevant to my upcoming surgery, and is my heart risk profile the kind this trial is designed for?
2The trial is measuring how many patients develop myocardial injury after non-cardiac surgery, which can happen without obvious symptoms. How would my heart be monitored during and after surgery in this trial compared to what I'd get with standard care?
3Since this is a Phase 4 trial, the drug itself has already been approved for other uses, but its use specifically to prevent post-surgical heart injury is still being studied. Does that mean the safety profile is better understood than in earlier-phase trials, and what risks should I still be aware of in this specific context?
4GLP-1 receptor agonists can have side effects like nausea, vomiting, or delayed stomach emptying, which could matter a lot around the time of surgery. How might those side effects interact with my surgical recovery, and is my care team comfortable managing them?
5Are there standard preventive strategies already used to reduce heart injury risk after non-cardiac surgery that I should consider alongside or instead of enrolling in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.