SGLT2 Inhibition in Combination With Diuretics in Heart Failure

PHASE4CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

December 11, 2017

Primary Completion Date

December 11, 2018

Study Completion Date

January 9, 2019

Conditions
Heart FailureType 2 Diabetes Mellitus
Interventions
DRUG

Empagliflozin 25mg

Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks

DRUG

Placebo oral capsule

Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks

DRUG

Frusemide

Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered.

Trial Locations (1)

DD1 9SY

University of Dundee, Ninewells Hospital and Medical School, Dundee

All Listed Sponsors
collaborator

British Heart Foundation

OTHER

lead

University of Dundee

OTHER

NCT03226457 - SGLT2 Inhibition in Combination With Diuretics in Heart Failure | Biotech Hunter | Biotech Hunter