Clinical trial NCT00989508: Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
Official title: Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myocardial Reperfusion Injury
Cardiac Output, Low
Hypertrophy, Left Ventricular
Keywords: Perhexiline
Aortic Valve Stenosis
Hypertrophy, Left Ventricular
Myocardial Reperfusion Injury
Cardiac Output, Low
Troponin
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: Brighton and Sussex University Hospitals NHS Trust
name: British Heart Foundation
First posted: 2009-10-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute difference in Cardiac Index (>0.3 l/min/m2)
timeFrame: 6 hours post-removal of aortic X-clamp
Secondary outcomes:
measure: Incidence of Low Cardiac Output Syndrome
timeFrame: 6 hours post-removal of aortic X-clamp
measure: Incidence of inotrope use according to protocol
timeFrame: 6 and 12 hours post-removal of aortic X-clamp
measure: Peak and total release of Troponin
timeFrame: 12 and 24 hours post-release of aortic X-clamp
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham
name: Domeinco Pagano, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quinn DW, Pagano D, Bonser RS, Rooney SJ, Graham TR, Wilson IC, Keogh BE, Townend JN, Lewis ME, Nightingale P; Study Investigators. Improved myocardial protection during coronary artery surgery with glucose-insulin-potassium: a randomized controlled trial. J Thorac Cardiovasc Surg. 2006 Jan;131(1):34-42. doi: 10.1016/j.jtcvs.2005.05.057.
citation: Ranasinghe AM, Quinn DW, Pagano D, Edwards N, Faroqui M, Graham TR, Keogh BE, Mascaro J, Riddington DW, Rooney SJ, Townend JN, Wilson IC, Bonser RS. Glucose-insulin-potassium and tri-iodothyronine individually improve hemodynamic performance and are associated with reduced troponin I release after on-pump coronary artery bypass grafting. Circulation. 2006 Jul 4;114(1 Suppl):I245-50. doi: 10.1161/CIRCULATIONAHA.105.000786.
citation: Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. doi: 10.1111/j.1527-3466.2007.00006.x.