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Polydiuretic Therapy for HFpEF, a Randomised Controlled Trial

NCT05129722 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Low dose combination polydiuretic therapy

Low dose combination polydiuretic therapy treatment consists of: Loop diuretic bumetanide 0.5 mg Mineralocorticoid receptor antagonist eplerenone 25 mg Sodium-glucose co-transporter 2 inhibitor (SGLT2i): empagliflozin 10mg

DRUG

Comparator monotherapy empagliflozin

Sodium-glucose co-transporter 2 inhibitor (SGLT2i): empagliflozin 10mg

Sponsors & Collaborators

  • Victor Chang Cardiac Research Institute

    collaborator UNKNOWN

  • St Vincent's Centre for Applied Medical Research

    collaborator UNKNOWN

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • The George Institute

    lead OTHER

Principal Investigators

  • Clare Arnott · The George Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129722 on ClinicalTrials.gov