22 August 2012
Date opened: TBC
Type: RandomisedRandomised means that patients accepted into the study are randomly allocated to receive one or other of the alternative treatments., double-blindedA double-blinded trial means that neither the patient nor the researchers know whether any given individual has received which of the different treatments until after the data has been collected and analysed., placebo-controlledA placebo is a drug designed to have no real effect on the patient. A placebo-controlled study means that some patients will receive the drug being tested and other patients receive a placebo. This enables researchers to compare how patients respond to the drug and the placebo. .
Phase: Phase 3
Current Status: Pending approval
Recruitment to date: None (Target TBC)
Lead researchers: Dr Andy Johnston and Maj Mark Foster
The Harp-2 trial is designed to test the hypothesis that patients with a condition called acute lung injury (ALI) will benefit from treatment with a specific daily dose of a drug called simvastatin for up to 28 days.
ALI is a condition in which the lungs do not function properly, particularly featuring:
- Fluid build-up in the smallest spaces of both lungs, called the alveolar spaces, visible on a chest X-ray. This phenomenon is called bilateral pulmonary infiltrates.
- Reduced pressure in the small blood vessels in the lungs, known as pulmonary capillary wedge pressure.
ALI is known to develop in some patients who are given a transfusion of large amounts of blood, usually after surgery or a traumatic injury. The specific reasons for this are not fully understood, but one possibility is an inflammatory response which weakens the small blood vessels in the lungs and leads to the pulmonary infiltrates.
Although 22 trials of 14 different drugs have been carried out in a search for a treatment for ALI, none have led to a definitive method of treating the condition.
Simvastatin is a one of the statin class of drugs, which is widely used to reduce cholesterol in patients with conditions affecting the heart and circulation (cardiovascular disease). Researchers have found evidence in a small trial that simvastatin plays a role in inflammatory conditions such as ALI, as it helps to stabilise the lining of blood vessels.
This is why they want to investigate its effectiveness in a wider clinical setting.
Who is eligible?
Patients who have been diagnosed with ALI and are receiving invasive mechanical ventilation in critical care will be assessed for suitability to take part based on a number of standard tests.
A Phase 2 trial involving 60 patients at a hospital in Northern Ireland showed improvements in the condition of ALI patients after 14 days of receiving simvastatin, with acceptable side effects.
This Phase 3 trial expands the number of patients involved. Patients with ALI who meet certain criteria will be approached to take part in the study within 48 hours of the onset of ALI.
Those patients who consent to take part will be randomised, which means their details are entered into a computer database. The database assigns them to receive either simvastatin or a placebo.
The study is double-blinded. This means that the patient will not know if they are receiving simvastatin or the placebo, and neither will the clinician who is administering the drug/placebo.
The patients will receive the drug/placebo every day for 28 days, and their condition will be monitored using blood and urine samples while they are still in hospital and after discharge at set points for up to 12 months.
The primary outcome measure for this trial is the number of ventilator free days recorded for the patient in the first 28 days after they have been randomised. Mechanical ventilation is used to support the patient’s breathing while their lungs are not functioning properly, and treatment aims to enable the patient to breathe on their own. Researchers will count the number of full days the patient does not require a ventilator in the first 28 days after randomisation.