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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract 2006-003164-62 | |||
| REC 06/Q0104/141 | |||
| BHF PG/06/044/20703 |
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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. 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 | 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 |
|---|---|---|
| Incidence of Low Cardiac Output Syndrome | 6 hours post-removal of aortic X-clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Cardiac index of greater than or equal to 0.3 L/min/m2 | 6 hours post-removal of aortic X-clamp | |
| Incidence of inotropes 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 | Affiliation | Role |
|---|---|---|
| Domeinco Pagano, MD FRCS | University Hospital Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Birmingham | Birmingham | West Midlands | B15 2TH | United Kingdom | ||
| Brighton & Sussex University Hospitals NHS Trust |
| 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 |
| 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 | 6, 12 and 24 hours post-release of aortic X-clamp |
| Brighton |
| West Sussex |
| BN2 5BE |
| United Kingdom |
| 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. |
| 24948413 | Derived | Drury NE, Howell NJ, Calvert MJ, Weber RJ, Senanayake EL, Lewis ME, Hyde JA, Green DH, Mascaro JG, Wilson IC, Graham TR, Rooney SJ, Viant MR, Freemantle N, Frenneaux MP, Pagano D; investigators. The effect of perhexiline on myocardial protection during coronary artery surgery: a two-centre, randomized, double-blind, placebo-controlled trial. Eur J Cardiothorac Surg. 2015 Mar;47(3):464-72. doi: 10.1093/ejcts/ezu238. Epub 2014 Jun 19. |
| D014652 |
| Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |