Polydiuretic Therapy for HFpEF, a Randomised Controlled Trial
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
Heart Failure (HF) in Australia affects 1-2% of the population. Heart failure with preserved
ejection fraction (HFpEF) refers to a syndrome of clinical heart failure without impairment
of systolic cardiac function. HFpEF has few therapeutic agents that are proven to improve
outcomes and it was only recently, the published EMPEROR-Preserved trial demonstrated that
empagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i) reduced composite outcome
of heart failure hospitalisation and cardiovascular death by 21% among patients with
HFpEF.[1] HFpEF therapies have traditionally aimed at providing symptomatic relief and
treating coexisting illnesses.
This multi-centre randomised clinical trial aims to establish the feasibility of a fixed low
dose combination polypill consisting of bumetanide 0.5 mg, eplerenone 25 mg, and
empagliflozin 10 mg in patients with HFpEF compared against empagliflozin 10 mg monotherapy
in patients with HFpEF.
Fixed dose combination low dose diuretics of this nature have not been rigorously studied in
patients with HFpEF, and this study aims to help improve the treatment paradigm for this
patient population.
Phase:
Phase 4
Details
Lead Sponsor:
The George Institute
Collaborators:
St Vincent's Centre for Applied Medical Research Victor Chang Cardiac Research Institute