Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy (HYPER)

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hypertrophy, Left Ventricular; Myocardial Reperfusion Injury; Cardiac Output, Low

Treatments: Drug: Perhexiline; Drug: Placebo marked PEXSIG

Study type: Interventional

Funder types: Other

Identifiers

NCT00989508

REC 08/H0304/48

Eudract 2008-002376-95

BHF PG/08/040

RRK3535

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Perhexiline

Experimental group

Description:

Pre-operative administration of Perhexiline tablets according to dosing schedule

Treatment:

Drug: Perhexiline

Placebo marked PEXSIG

Placebo Comparator group

Description:

Pre-operative administration of placebo tablets according to dosing schedule

Treatment:

Drug: Placebo marked PEXSIG