HARP-2 HARP-2 logo

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
RECRUITMENT
Date Closed to Recruitment March 2014
Target Recruitment 540
Recruitment to date 540
TRIAL DESIGN
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 (CI)
Chief Investigator Professor Danny McAuley (UK) / Professor John Laffey (IRE)
SPONSOR(s) & FUNDER(s)
Sponsors Belfast Health and Social Care Trust and National University Ireland Galway
Funder NIHR_Efficacy and Mechanism Evaluation (EME)

This project was awarded by the Efficacy and Mechanism Evaluation (EME) Programme and is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. It is managed by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton http://www.eme.ac.uk.

The views expressed on this website are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.

EME
Funder Health Research Board (HRB)

The Health Research Board (HRB) supports excellent research that improves people’s health, patient care and health service delivery. We aim to ensure that new knowledge is created and then used in policy and practise. In doing so, we support health system innovation and create new enterprise opportunities

EME