ISRCTN12903789
Active, not recruiting
Phase 2
Targeted heart rate control using the funny current inhibitor ivabradine to reduce morbidity in patients undergoing non-cardiac surgery: a phase IIa, triple blind, placebo controlled randomised trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Queen Mary University of London
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria of as 07/03/2023:
- •1\. Patients aged 55 years and over
- •2\. Undergoing elective or urgent non\-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia
- •3\. At least one medical risk factor for perioperative myocardial injury
- •4\. History of hypertension (requiring anti\-hypertensive drug) or hypertension recorded in the pre\-assessment clinic \[BP\>140mmHg systolic; \>90 mmHg diastolic]
- •Previous participant inclusion criteria:
- •1\. Patients aged 55 years and over
- •2\. Undergoing elective or urgent non\-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia
- •3\. At least one medical risk factor for perioperative myocardial injury
Exclusion Criteria
- •Current participant exclusion criteria of as 07/03/2023:
- •1\. Inability or refusal to provide informed consent
- •2\. Patients lacking capacity
- •3\. Prior use of ivabradine within the previous 30 days
- •4\. Current participation in a clinical trial of a treatment with a similar biological mechanism
- •5\. Previous enrolment into FUNNY trial
- •6\. Contraindication to ivabradine
- •7\. History of hypersensitivity or allergy to ivabradine or any of its excipients
- •8\. Women of childbearing potential (this includes pregnancy and lactation). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant unless permanently sterile
- •9\. Patients with atrial fibrillation (persistent/chronic or paroxysmal)
Outcomes
Primary Outcomes
Not specified
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