SGLT2 Inhibition in Combination With Diuretics in Heart Failure

• Status: Completed
• Trial end date: 2019-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The RECEDE-CHF trial is a single centre phase IV, randomised, double-blind, placebo-controlled, crossover trial conducted in NHS Tayside, Scotland comparing empagliflozin 25mg, to placebo in patients with Type 2 Diabetes and mild Chronic Heart Failure with left ventricular systolic dysfunction who are already on a loop diuretic. Renal physiological testing will be performed at two points on each arm to assess the effect of empagliflozin, on urinary volume, compared to placebo. The secondary outcomes are to assess the effect of empagliflozin in addition to loop diuretics on natriuresis, to assess the safety of add-on SGLT2 inhibitor therapy as measured by changes to serum creatinine and eGFR, to assess effects of empagliflozin on urinary protein/creatinine ratio, albumin/creatinine ratio and cystatin C when compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborator: British Heart Foundation
• Treatments: Diuretics; Empagliflozin; Furosemide

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.