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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract 2008-002376-95 | |||
| REC 08/H0304/48 | |||
| BHF PG/08/040 |
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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
| Brighton and Sussex University Hospitals NHS Trust | OTHER |
| British Heart Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perhexiline | Experimental | Pre-operative administration of Perhexiline tablets according to dosing schedule |
|
| Placebo marked PEXSIG | Placebo Comparator | Pre-operative administration of placebo tablets according to dosing schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perhexiline | Drug | Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute difference in Cardiac Index (>0.3 l/min/m2) | 6 hours post-removal of aortic X-clamp |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eshan Senanayake, MBBS MRCS | Contact | +44-7810-251454 | eshan.senanayake@uhb.nhs.uk | |
| Nigel E Drury, BM MRCS | Contact | +44-7714-332364 | nigel.drury@uhb.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Domeinco Pagano, MD FRCS | University Hospital Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Birmingham | Recruiting | Birmingham | West Midlands | B15 2TH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16399292 | Background | 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. | |
| 16820580 |
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| ID | Term |
|---|---|
| D015428 | Myocardial Reperfusion Injury |
| D002303 | Cardiac Output, Low |
| D017379 | Hypertrophy, Left Ventricular |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D010480 | Perhexiline |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo marked PEXSIG | Drug | Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days. |
|
| Peak and total release of Troponin |
| 12 and 24 hours post-release of aortic X-clamp |
| 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. |
| 17445089 | Background | 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. |
| D014652 |
| Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |