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.