Ivabradine in the Prevention of Cardiac Injury in patients undergoing major Orthopaedic surgery.

Phase 2

• Conditions: Cardiac injury; Mortality; Orthopaedic Surgery; Cardiovascular - Other cardiovascular diseases; Injuries and Accidents - Fractures

• Registration Number: ACTRN12616001634460
• Lead Sponsor: Department of Cardiology, Northern Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients above the age of 60 undergoing major Orthopaedic surgery (related to long bones, such as femur fractures), who understand and willing to comply with study activities.

Exclusion Criteria

Bradycardia (heart rates below 60 beats per minute)
Current Ivabradine (study intervention drug) use
Patient's with pacemaker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peri-operative myocardial injury (PMI) after undergoing major orthopaedic surgery. PMI is defined by troponin I levels above 0.04 mcg/L (if baseline was 0.04 mcg/L or less), or rise in blood levels of troponin I above 20% (if baseline was above 0.04 mcg/L).<br><br>Troponin I levels will be measured from bloods samples, collected at randomisation, and days 1, 2 and 3 post-operatively.[Post-operative days 1, 2, of 3.]

Secondary Outcome Measures

Name	Time	Method
Clinically significant hypotension, defined by symptomatic systolic blood pressure below 90 mmHg requiring active intervention, such as intravenous fluids or vasopressors, at the discretion of the treating clinician.<br><br>This outcome will be assessed from the review of medical records, based on daily blood pressure charts, as well as clinical notes from the attending physician.[Post-operative days 1, 2, and 3.];Mortality[30-day and 1 year.]