Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Cardiac Output, Low Clinical Trial

— HYPER  

Official title:

Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00989508
• Other study ID #: RRK3535
• Secondary ID: Eudract 2008-002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 2, 2009
• Last updated: August 10, 2011
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: University Hospital Birmingham
• Contact: Eshan Senanayake, MBBS MRCS
• Phone: +44-7810-251454
• Email: eshan.senanayake[@]uhb.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output, Low
• Hypertrophy
• Hypertrophy, Left Ventricular
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Drug:
• Perhexiline
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
• Placebo marked PEXSIG
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham	Birmingham	West Midlands

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Birmingham	Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute difference in Cardiac Index (>0.3 l/min/m2)		6 hours post-removal of aortic X-clamp	No
Secondary	Incidence of Low Cardiac Output Syndrome		6 hours post-removal of aortic X-clamp	No
Secondary	Incidence of inotrope use according to protocol		6 and 12 hours post-removal of aortic X-clamp	No
Secondary	Peak and total release of Troponin		12 and 24 hours post-release of aortic X-clamp	No