PIROUETTE
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, phase 2 study of the efficacy and safety of pirfenidone in patients with heart failure and preserved left ventricular ejection fraction.
IRAS ID
202204
Contact name
Christopher Miller
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2016-002647-42
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
It is known that in about half of patients with heart failure, the pumping function of the heart is normal. Crucially, there are NO treatments for this kind of heart failure. Scarring of the heart appears to be particularly important in these patients. Pirfenidone is a relatively new treatment that reduces scar tissue. In patients with lung scarring it reduces the amount of scar tissue. This leads to an improvement in quality of life and prognosis in these patients.
This study will assess if pirfenidone reduces the amount of heart scarring in patients with heart failure with normal pumping function. Patients with heart scarring will be given pirfenidone or a dummy drug (placebo) for 1 year. The change in the amount of heart scarring will be compared between those receiving pirfenidone and those receiving placebo.
It is not known why heart scarring is bad. One possibility is that when heart cells are surrounded by scar tissue they do not get a good enough blood supply, and therefore do not have the energy they need to work properly. This study will also use MRI scanning to assess heart muscle energy in some of the patients included in the study. The relationship between heart scarring and energy will be measured, and the effect of pirfenidone on heart energy will be assessed.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0717
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion