Status:
COMPLETED
PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery
Lead Sponsor:
University Hospital, Geneva
Conditions:
Myocardial Injury
Myocardial Ischemia
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
Perioperative myocardial injury (PMI) after non-cardiac surgery (NCS), i.e. the elevation of postoperative troponin, occurs in nearly 20% of patients older than 45 years undergoing NCS and is independ...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature of patient; AND
- Undergoing intermediate or high-risk non-cardiac surgery (as defined in European Society of Anaesthesiology guidelines) AND;
- One of the following:
- o≥ 75 years old OR; o≥ 45 years old AND at least 1 risk factors independently associated with perioperative myocardial injury (history of coronary artery disease, chronic heart failure, peripheral artery disease, ischemic stroke, hypertension, diabetes mellitus, chronic kidney disease).
Exclusion
- Inability to provide informed consent;
- History of hypersensitivity or allergy to ivabradine;
- Emergency surgery (to be done within 24h of diagnosis);
- Shock or acute decompensated heart failure at trial inclusion;
- Low cardiac output syndrome;
- Arrhythmia:
- Atrial fibrillation or flutter;
- AV-block of 3rd degree;
- Sick sinus syndrome;
- Sino-atrial block;
- Pacemaker dependency;
- Unstable angina;
- Acute myocardial infarction in the 3 months preceding the trial;
- Stroke in the 3 months preceding the trial;
- Cirrhosis Child B and C;
- Renal failure with a Estimated Glomerular filtration rate ≤ 15 ml/min/1.73m2;
- Treatment with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin; josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone;
- Treatment with verapamil or diltiazem which are moderate CYP3A4 inhibitors and PGP inducers with heart rate reducing properties;
- Women who are pregnant or breast feeding;
- Childbearing potential (Of note, woman with history of hysterectomy, surgical sterilization or menopause for longer than 2 years are not considered with childbearing potential, independent of their age);
- Participation in another study with investigational drug within the 30 days preceding and during the present study;
- Previous enrolment into the current study.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04436016
Start Date
October 5 2020
End Date
January 11 2022
Last Update
March 2 2022
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Switzerland