| Trial Acronym | Prevention HARP-2 |
| Clinical Area | Critical Care |
| Trial Title | “Prevention Of Post-operative Complications By Using HMG-CoA Reductase Inhibitor In Patients Undergoing Oesophagectomy – A multicentre, randomised, double blind, placebo controlled trial” |
| Status | Analysis & Reporting |
| Trial Registration | http://www.controlled-trials.com/ISRCTN48095567 |
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Recruitment
Recruitment Target 452 Date Open to Recruitment October 2016 Recruitment 251 Date Closed to Recruitment September 2022 -
Trial Design
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
Chief Investigator Dr Murali Shyamsundar Email Murali.Shyamsundar@belfasttrust.hscni.net -
Sponsor & funder
Sponsor 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. National Institute for Health Research, CDV/5137/15