SGLT2 Inhibition in Combination With Diuretics in Heart Failure

Launched by UNIVERSITY OF DUNDEE · Jul 20, 2017

Keywords

ClinConnect Summary

Type 2 Diabetes (T2D) and Heart Failure (HF) are a frequent combination, where treatment options remain limited. There has been increasing interest around the sodium-glucose co-transporter 2 (SGLT2) inhibitors and their use in patients with HF. This is following publication of EMPA-REG OUTCOME trial that reported a 14% reduction in the primary composite outcome of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and \>30% reductions in cardiovascular mortality, overall mortality and HF hospitalisations in patients randomised to the SGLT2 inhibitor, empagliflozin, when...

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of NYHA Functional class II-III HF with prior echocardiographic evidence of LVSD.
• • On stable doses of furosemide, or alternative loop diuretic for at least one month.
• • Stable Type 2 Diabetes (HbA1c, in the last 3 months, of 6.5% ≤ and ≤10.0%)
• • eGFR ≥ 45 ml/min.
• • Have stable HF symptoms for at least three months prior to consent
• • On stable HF therapy for at least three months prior to consent
• • Have not been hospitalised for HF for at least three months prior to consent.
• • Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
• Exclusion Criteria:
• • A diagnosis of chronic liver disease and/or liver enzymes that are twice the upper limit of normal
• • Systolic BP of \<95mmHg at screening visit.
• • Participants on thiazide diuretics.
• • Participants receiving renal dialysis
• • Participants who have previously had an episode of diabetic ketoacidosis.
• • Participants with type 1 diabetes mellitus
• • Malignancy (receiving active treatment) or other life threatening disease.
• • Pregnant or lactating women
• • Participants with difficulty in micturition e.g. severe prostate enlargement
• • Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
• • Past or current treatment with any SGLT2 inhibitor
• • Participants who have participated in any other clinical interventional trial of an investigational medicinal product within 30 days.
• • Participants who are unable to give informed consent
• • Any other reason considered by the physician to be inappropriate for inclusion.