Research project
Title: HARP-2: Treatment with Simvastatin in Acute Lung Injury
Project timescale: From 01 September, 2010 to 01 September, 2015
(Added to website on: 02 October, 2012 - Date last updated: 31 January, 2013)
Source of funding:
Medical Research Council (MRC)
Some additional funding provided by the Health Research Board
Aims: The aim of this study is to test the hypothesis that treatment with enteral (given through a small tube inserted in the mouth or nose which leads to the stomach) simvastatin 80mg once daily for a maximum of 28 days will be of therapeutic value in patients with acute lung injury. 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 acute lung injury. Objective 2: To study the biological effect of simvastatin treatment on: (2a) systemic markers of inflammation; (2b) systemic cell-specific indices of activation and injury to the lining of the lungs; (2c) lung extracellular matrix degradation; (2d) assess whether a response to simvastatin is determined by the patient's genetic make up (that is whether a patient's genes have an effect on how the patient responds to medicines or illness or their recovery).
Research designs used:
Randomised controlled trial
Other:
Methods used to collect data:
Validated instruments eg Outcome measures
Questionnaire survey
Other (please specify): Patient data will be collected and recorded in a HARP-2 case report form from the point of patient randomisation, daily for the 28 days duration of the patient involvement in the study.
Research project description: When people become critically ill, for various reasons including severe infection or following injury in a road traffic accident, their lungs often fail, which is termed "acute respiratory distress syndrome" (ARDS). ARDS is primarily caused by the body’s immune system response to the injury; is common; can affect any age group and is commonly fatal. Furthermore, even after recovery from lung injury, patients subsequently experience a poorer quality of life. Many survivors of this condition are unable to return to work or look after themselves. Unfortunately, to date there is currently no effective treatment for this lung injury. The HARP-2 study is designed to investigate if the drug simvastatin, commonly used to treat high cholesterol, is safe and effective in the treatment of this lung injury. The study will take place over 5 years in Intensive Care Units (ICU’s) in Ireland and in the United Kingdom. People suffering from ARDS will be randomly divided into two groups; one group will be given the active drug and the other a dummy drug with no activity (placebo). This design means that any difference in the experience of patients will be due to whether or not they received simvastatin and not to any other difference that could influence the outcome of treatment. The study team comprises experts in study design, senior doctors who work in critical care units, and experts in ARDS. We will also take blood samples to measure markers of inflammation which will allow us to determine if simvastatin can reduce the immune response which causes the lung injury. In addition, we will determine how severe the damage to the patients’ lungs is, and how fast they recover. If simvastatin is effective, it would help save the lives of these sufferers, improving the quality of life of survivors and potentially reduce costs, by reducing time spent in Intensive Care Units.
Stages at which the public were involved:
Planning the research
Designing the research instruments
(eg questionnaires, patient information sheets)
Disseminating research
Seeking funding / applying for funding
Other: Trial oversight
Description of public involvement in research stages: The Chair of the Intensive Care Society Patient Liaison Committee (CritPal) has contributed to patient centered outcomes and the design of the patient information sheet. He will also have an input into dissemination of the research project.
Training and support provided for either members of the public or researchers involved in the project:
Examples of ways the public have made a difference to the research project: The Chair of the Intensive Care Society Patient Liaison Committee (CritPal) has reviewed the HARP-2 study protocol; contributed to the design of the patient information sheet and sits on the HARP-2 Trial Steering Committee.
Evaluating the impact of public involvement in the research: We have not considered this to date, but will discuss as a possibility amongst the research team.
Details of publications or reports resulting from the research: The research project is presently in the recruitment stage.
Links to Reports:
Was/is your project user controlled: No
For further information on the project, please contact:
Mrs Christine McNally
Clinical Trials Manager
Clinical Research Support Centre
1st Floor, Eliott Dynes Building
Royal Hospitals
Grosvenor Road
Belfast
Co Antrim
BT12 6BA
United Kingdom
harp2@crsc.n-i.nhs.uk
028 9063 5794
DISCLAIMER
Each entry has been written by the individual project and although care has been taken in compiling, checking and updating the information on this site INVOLVE and the National Institute for Health Research (NIHR) cannot guarantee its correctness and completeness. We do not accept responsibility for any loss, damage or expense resulting from the use of this information.
