Not Yet RecruitingPhase 2ACTRN12616001634460

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

Ivabradine in the Prevention of Peri-operative Myocardial Injury in patients undergoing major Orthopaedic surgery,


Sponsor

Department of Cardiology, Northern Hospital

Enrollment

200 participants

Start Date

Dec 1, 2016

Study Type

Interventional

Conditions

Summary

During or after a major operation (such as bones or joints operations, also known as orthopaedic operations), our body increases its heart rate as a response to the stress of the surgery. As the heart pumps faster to manage the stress, it can sometimes damage itself in the process. As previous study observed that up to 52% of patients undergoing major orthopaedic operations demonstrated some evidence of injury to the heart, and these patients have poorer clinical outcomes. This has led to previous studies examining the benefits of heart rate lowering agents to prevent damage to the heart after surgery, to improve clinical outcomes. Unfortunately, many heart rate lowering agents have a common side effect of lowering the blood pressure as well. Hence, whilst these trials demonstrated promising benefit in reducing damage to the heart, they caused significant problems with low blood pressure. Ivabradine is an agent that reduces heart rate, but does not drop blood pressure. It is currently approved for use in Australia for another condition called chronic heart failure. But given its unique properties, we postulate that it can reduce damage to the heart after a major operation as well, without the negative effect of causing low blood pressure. As a result, this trial was conceived to examine this effect.


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Inclusion Criteria1

  • 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 Criteria3

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

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Interventions

Patients undergoing major Orthopaedic Surgery will be randomised to receive Ivabradine (Arm 1) above standard of care, or no intervention (Arm 2: usual standard of care). Ivabradine will be dosed a

Patients undergoing major Orthopaedic Surgery will be randomised to receive Ivabradine (Arm 1) above standard of care, or no intervention (Arm 2: usual standard of care). Ivabradine will be dosed at 5mg, orally, twice a day for patients with initial heart rate of 60-90 beats per minute (at randomisation), OR 7.5mg orally twice a day for heart rates of >90 beats per minute. First dose of medication will commence between 2 - 48 hours prior to surgery, and continue for a total of 7 days. Once a patient is scheduled for major orthopaedic surgery (with an estimate of date and time), information regarding trial will be provided. Once informed consent is obtained, randomisation will take place and first dose of medication commenced immediately after randomisation. If surgery is expected to be delayed by more than 48 hours, the patient will be withdrawn from study, as it does not fit with the intended study population (requiring emergent surgery). If surgery is expected to take place within 2 hours of study medication becoming available to the patient, the patient will be withdrawn as well, as it is considered too short a period for the medication to reach effect pre-operatively. All patients will be interviewed at 30 days, and compliance will be assessed accordingly.


Locations(1)

The Northern Hospital - Epping

VIC, Australia

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ACTRN12616001634460


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