Trial Acronym | HARP-2 |
Clinical Area | Critical Care |
Description | Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction. |
Status | Closed |
Date Closed to Recruitment | March 2014 |
Target Recruitment | 540 |
Recruitment to date | 540 |
Trial Design | Prospective, Randomised, Double-Blind,Placebo-Controlled Phase-II Multi-Centre Trial of Simvastatin in Patients with ALI. |
Study Aim | The aim of this study is to test the hypothesis that treatment with enteral simvastatin 80mg once daily for a maximum of 28 days will be of therapeutic value in patients with ALI. The study has two distinct objectives: |
Objective 1: To conduct a prospective randomised, double-blind, placebo-controlled phase II multi-centre trial of simvastatin for the treatment of ALI. | |
Objective 2: To study the biological mechanisms of simvastatin treatment on: (2a) systemic markers of inflammation; (2b) systemic cell-specific indices of activation and injury to the alveolar epithelium and endothelium; (2c) lung extracellular matrix degradation; (2d) assess whether response to simvastatin is determined by genetic polymorphisms as well as link genotypic information to the phenotypic information recorded as part of this study. |
Chief Investigator | Professor Danny McAuley (UK) / Professor John Laffey (IRE) |
Sponsors | Belfast Health and Social Care Trust and National University Ireland Galway |
Funder | NIHR_Efficacy and Mechanism Evaluation (EME)
|
Funder | Health Research Board (HRB)
|