Can pre-operative Ivabradine and/or Atorvastatin prevent heart injury following surgery for neck of femur fracture in elderly patients?

Phase 4

• Conditions: Coronary artery disease; Fractures; Peri-operative myocardial injury; Surgery - Other surgery; Cardiovascular - Coronary heart disease; Injuries and Accidents - Fractures

• Registration Number: ACTRN12612000340831
• Lead Sponsor: orthern hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

1) Age greater than 60 years
2) Neck of femur fracture with planned surgical treatment within 48 hours

Exclusion Criteria

1) Current ivabradine use
2) Patients who do not undergo surgical treatment for lower limb fracture for any reason. If such patients were initially enrolled they will be excluded from the analysis, i.e per protocol analysis.
3) Heart rate < 65bpm prior to randomisation
4) Known liver disease or liver enzymes > 3 times the higher limits of normal
5) Pre-operative troponin elevation
6) Artificial pacemakers, sick sinus syndrome or complete heart block
7) Concomittant CYP3A4 inhibitors – ketoconazole, macrolides, cyclosporin, gestodene, antiretrovirals

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency (binary outcome) and magnitude (continuous variable) of new myocardial injury following emergent orthopaedic surgery for lower limb fracture as assessed by troponin I, on a per protocol basis.[Day 0<br>Day 1<br>Day 2<br>Day 3]

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction according to the universal definition[Day 3];Mean HR over 48 hours Holter monitoring postoperatively[48 hours];Incidence and duration of AF over 48 Holter monitoring postoperatively[48 hours];Serum assays of NT-proBNP, MR-proANP, MR-proADM and CT-proET-1. Samples would be stored at negative 80 degrees prior to testing at external laboratory.[Days 0,1,2,3];Serum assays of sPLA2 and Lp-PLA2 mass and activity[Days 0,1];Platelet activation as measured by VerifyNow P2Y12 assay.[Preoperative (day 0)];Death[In hospital<br>30 days<br>12 months];Stroke[In hospital<br>30 days<br>12 months];Symptomatic bradycardia or heart block requiring cessation of ivabradine[In hospital];Liver enzyme elevation > 3 times the upper limits of normal[In Hospital]