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

Phase 2

• Conditions: Heart Failure with Reduced Ejection fraction; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000187842
• Lead Sponsor: The Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-22
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified