Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
HYPER
4 other identifiers
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 11, 2011
April 1, 2011
2.9 years
October 2, 2009
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute difference in Cardiac Index (>0.3 l/min/m2)
6 hours post-removal of aortic X-clamp
Secondary Outcomes (3)
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
Study Arms (2)
Perhexiline
EXPERIMENTALPre-operative administration of Perhexiline tablets according to dosing schedule
Placebo marked PEXSIG
PLACEBO COMPARATORPre-operative administration of placebo tablets according to dosing schedule
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult
- First-time
- Aortic valve surgery for aortic stenosis +/- coronary artery bypass
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Birminghamlead
- University of Birminghamcollaborator
- Brighton and Sussex University Hospitals NHS Trustcollaborator
- British Heart Foundationcollaborator
Study Sites (1)
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (3)
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.
PMID: 16399292BACKGROUNDRanasinghe 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.
PMID: 16820580BACKGROUNDAshrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. doi: 10.1111/j.1527-3466.2007.00006.x.
PMID: 17445089BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Domeinco Pagano, MD FRCS
University Hospital Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 5, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
August 11, 2011
Record last verified: 2011-04