| Trial Acronym | Prevention HARP-2 |
| Clinical Area | Critical Care |
| Description | “Prevention Of Post-operative Complications By Using HMG-CoA Reductase Inhibitor In Patients Undergoing Oesophagectomy – A multicentre, randomised, double blind, placebo controlled trial” |
| Status | Open to recruitment |
| Date Opened to Recruitment | October 2016 |
| Target Recruitment | 452 |
| Recruitment to date | 1 |
| Date Closed to Recruitment | N/A |
| No. of Sites | 6 |
| Trial Design | “(i) Type of study – interventional (ii) Study design including: – Randomised – Placebo controlled – Parallel – Purpose – Prevention – Phase II” . |
| Study Aim | The aim of this study is to test the hypothesis that treatment with enteral simvastatin 80mg once daily for four days pre-surgery and up to 7 days post-surgery will prevent the development of cardiac and respiratory complications in patients undergoing one lung ventilation for elective oesophagectomy, lobectomy or pneumonectomy. |
| Objective 1: To conduct a prospective randomised, double-blind, placebo-controlled phase II multi-centre trial of simvastatin for the prevention of cardiac and pulmonary complications in patients undergoing elective oesophagectomy, lobectomy or pneumonectomy. | |
| “Objective 2: To study the biological mechanisms of simvastatin treatment on: a. Systemic markers of inflammation; b. Systemic cell-specific indices of activation and injury to the alveolar epithelium and endothelium; c. Lung extracellular matrix degradation; (2d) systemic endothelial injury and effect on non-pulmonary organ dysfunction.” |
| Chief Investigator | Dr Murali Shyamsundar |
| Sponsors | Belfast Health and Social Care Trust |
| Funder | Public Health Agency (PHA) Health and Social Care Research and Development (HSC R&D) Office via a National Institute of Health Research (NIHR) Clinical Scientist Award. |
| Links | http://www.controlled-trials.com/ISRCTN48095567 |