GDF-15 in HFpEF
Research type
Research Study
Full title
Growth Differentiating Factor-15 in patients with Heart failure with Preserved Ejection Fraction - A biomarker sub study of the PIROUETTE Trial
IRAS ID
261110
Contact name
Christopher Miller
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Heart failure with preserved ejection fraction (HFpEF) represents one of the largest unmet needs in cardiovascular medicine (Bulter et al, 2014). Myocardial fibrosis, caused by chronic inflammation and excess collagen deposition, is central to HFpEF pathophysiology (Zile et al, 2015). As such, myocardial fibrosis is an important therapeutic target and anti-fibrotic agents are currently being assessed in HFpEF clinical trials. The pathophysiology of tissue fibrosis is a complex process, whereby numerous peptides and cell-markers are released into the serum and can be measured in the blood stream. Such markers are commonly called ‘biomarkers’, and allow a ‘window’ to monitor the fibrotic process and its response to intervention. Growth differentiating factor-15 (GDF-15) is an important biomarker of inflammation and myocardial fibrosis, and may provide important information into the effect of anti-fibrotic intervention in clinical trials of HFpEF patients.
The PIROUETTE study (NCT02932566 / 16/NW/0717) is a phase II randomised control study of patients with heart failure with preserved ejection and myocardial fibrosis. Patients are randomised to receive pirfenidone (an anti-fibrotic medication) or placebo for 12 months. Patients provide written informed consent to gift blood for storage at multiple time points over the 12-month treatment duration. Patients without myocardial fibrosis at baseline are entered into a registry-arm and are not randomised to receive intervention.
This study aims to assess and compare the longitudinal change in GDF-15 over a 12-month period in patients with HFpEF and established myocardial fibrosis, who have participated in the PIROUETTE trial. In addition, GDF-15 will be compared to patients with HFpEF and no evidence of myocardial fibrosis (non-randomised patients).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/0376
Date of REC Opinion
19 Feb 2019
REC opinion
Favourable Opinion