Effects of low-dose esmolol on heart injury in elderly patients after surgery
Official title: Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients:A Multicenter, Prospective, Double-blind, Randomized Controlled Study
Run by Qianfoshan Hospital · NCT05635877 · Data updated 2026-11-12
This study is testing whether giving low-dose esmolol to older patients before non-heart surgery can help reduce heart injury compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | February 7, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | March 29, 2023 |
| Trial ID | NCT05635877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are elderly patients aged 65 and older with a modified frailty index of 0.21 or higher who are scheduled for non-cardiac surgery.
✕Probably not a fit
Patients with a history of myocardial infarction, significant cardiac insufficiency, or severe lung disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the relationship between preoperative frailty and myocardial injury in elderly patients undergoing non-cardiac surgery. It aims to identify predictive factors for myocardial injury and evaluate the impact of low-dose esmolol on reducing such injuries. Esmolol, a selective β-adrenergic receptor blocker, is administered to manage heart rate and reduce myocardial oxygen consumption during the perioperative period. The study will compare outcomes between patients receiving esmolol and those receiving a placebo.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac outcomes and reduced myocardial injury in frail elderly patients undergoing non-cardiac surgery.
How similar studies have gone: Previous studies have shown promising results for the use of β-blockers like esmolol in reducing perioperative myocardial ischemia, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 65 years;
2. ASA: ⅰ-ⅳ;
3. Modified frailty index (mFI) ≥ 0.21;
4. Patients undergoing non-cardiac surgery.
Exclusion Criteria:
1. Refuse to participate;
2. Expected hospital stay \<3 days;
3. Preoperative β-blocker therapy;
4. History of myocardial infarction or coronary artery disease;
5. Preoperative bradycardia (heart rate \[HR\] \< 50 bpm) or arrhythmia;
6. Significant cardiac insufficiency (i.e., pulmonary artery pressure \>18 mm Hg, cardiac index ≤ 2.2 L/min/m 2);
7. Severe valvular heart disease;
8. Severe lung disease (e.g. asthma or chronic obstructive pulmonary disease);
9. Patients with perioperative troponin elevation due to nonischemic causes (e.g., sepsis, pulmonary embolism, arrhythmia);
10. The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause.
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Where it's running
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Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: yongtao Sun, PH.D
- Email: sunyongtao1979@163.com
- Phone: 18660795201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.