Cardiac Output, Low, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury
Conditions
Keywords
Perhexiline, Aortic Valve Stenosis, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury, Cardiac Output, Low, Troponin
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.
Interventions
DRUGPerhexiline
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Sponsors
University of Birmingham
Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
University Hospital Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute difference in Cardiac Index (>0.3 l/min/m2) | 6 hours post-removal of aortic X-clamp |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Contacts
Primary ContactEshan Senanayake, MBBS MRCS
Backup ContactNigel E Drury, BM MRCS
Outcome results
None listed