Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT04436016
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04436016
Study Brief:
Protocol Section:
NCT04436016