E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with left ventricular hypertrophy undergoing aortic valve surgery (with or without coronary artery surgery) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
During cardiac surgery, a cross-clamp is placed on the ascending aorta distal to the origin of the coronary arteries which results in complete cessation of blood flow through the myocardium. Perhexiline maleate is an anti-anginal drug that potently inhibits the mitochondrial FFA uptake enzymes CPT1 and CPT2, thus shifting myocaridal substrate metabolism from FFA to glucose. We hypothesise that preoperative loading with perhexiline in patients undergoing cardiac surgery on cardiopulmonary bypass will improve myocardial protection during cardiac surgery. |
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E.2.2 | Secondary objectives of the trial |
The secondary hypothesis is that enhances in myocardial protection are through improving energy conservation (high energy phosphates). |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The effects of metabolic manipulation on creatine kinase and adenosine triphosphate kinetics in left ventricular hypertrophy secondary to severe aortic stenosis. Version 1, 16/01/2010. This substudy will recruit 34 patients to assess energy conservation before and after surgery in patients with left ventricular hypertrophy using cardiac Magnetic Resonance Spectroscopy. |
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E.3 | Principal inclusion criteria |
Adult patients with left ventricular hypertrophy undergoing first-time aortic valve replacement surgery with or without coronary artery bypass surgery. |
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E.4 | Principal exclusion criteria |
Diabetes mellitus, renal impairment (serum creatinine> 200µmol/L), pregnancy, procedures involving other heart valves and surgery for catastrophic event. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of low cardiac output syndrome (LCOS) after surgery. This is an indicator of inadequate myocardial protection and for the purpose of this study, LCOS is defined as hypotension (mean arterial pressure <65 mmHg) with a cardiac index < 2.2 L/min/m2 in the presence of adequate filling pressures (CVP 8-12 mmHg, PCWP 12-16 mmHg) and heart rate (> 75 bpm) where systolic blood pressure < 90 mmHg and/or inotropic support +- intra-aortic balloon pump for >60 minutes to maintain such a clinical picture. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |