Mechanisms of action of SGLT2 inhibitors in patients with heart failure with reduced ejection fraction (HFrEF)

The Alfred Hospital0 sites36 target enrollmentFebruary 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 22, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

The Alfred Hospital

•LVEF less than or equal to 40%. NYHA II\-IV.
•Ischaemic or non\-Ischaemic aetiology.
•Stable heart failure therapy for 1 month (a \<50% adjustment to diuretics is permissible between day \-14 and day \-28\).
•Patients may be non\-diabetic or T2DM (on stable therapy \>12 weeks defined as \< ±20% variability in the average daily dose or oral agents and/or \< ±10% daily variability in insulin dose).

•Unstable heart failure or haemodynamics (eg SBP\<90mmHg, poorly controlled AF – rate\>90/min). Recent or active unstable coronary disease in the past 2 months or PCI with the past month or CABG within 3 months.
•Type 1 diabetes.
•Poorly controlled BSL (fasting plasma glucose level \> 13\.3 mmol/L).
•History of ketoacidosis or hyperosmolar state/coma within 6 months.
•Ongoing therapy with an SGLT2 inhibitor or GLP\-1 receptor agonist.
•On monoamine oxidase inhibitors or tricyclic antidepressants.
•Body mass index (BMI) \<20\.0 kg/m2 or \>40 kg/m2\.
•eGFR \<30 ml/min/1\.73 m2\.
•Other life limiting lesion (expected survival \<2 years) including malignancy, advanced respiratory, GI, neurologic, haematologic disease. Active substance abuse including EtOH.
•Inability to provide written informed consent.