Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Phase 2

• Conditions: Myocardial Reperfusion Injury; Cardiac Output, Low; Hypertrophy, Left Ventricular
• Interventions: Drug: Placebo marked PEXSIG; Drug: Perhexiline

• Registration Number: NCT00989508
• Lead Sponsor: University Hospital Birmingham

Brief Summary

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation.

This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Status Verified: 2011-04
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Adult
• First-time
• Aortic valve surgery for aortic stenosis +/- coronary artery bypass

Exclusion Criteria

• Diabetes Mellitus
• Renal impairment with Creatinine greater than or equal to 200micromol/L
• Atrial fibrillation
• Amiodarone therapy, recent (in last month) or current
• Hepatic impairment, significant preoperative
• Peripheral neuropathy
• Pregnancy or breast-feeding
• Emergency surgery or required on clinical grounds within 5 days of referral

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo marked PEXSIG	Placebo marked PEXSIG	Pre-operative administration of placebo tablets according to dosing schedule
Perhexiline	Perhexiline	Pre-operative administration of Perhexiline tablets according to dosing schedule

Primary Outcome Measures

Name	Time	Method
Absolute difference in Cardiac Index (>0.3 l/min/m2)	6 hours post-removal of aortic X-clamp

Secondary Outcome Measures

Name	Time	Method
Incidence of Low Cardiac Output Syndrome	6 hours post-removal of aortic X-clamp
Incidence of inotrope use according to protocol	6 and 12 hours post-removal of aortic X-clamp
Peak and total release of Troponin	12 and 24 hours post-release of aortic X-clamp

Trial Locations

Locations (1)

University Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom