Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.
This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo. Treatment will be continued until 30 days after index event, and primary efficacy measurements will be carried out during hospitalization and safety events until 60 days after index hospitalisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
10 mg daily, oral, 30 days
Matching Placebo, 10 mg daily, oral, 30 days
TREANT Zorggroep
Emmen, Drenthe, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
ISALA Klinieken
Zwolle, Overijssel, Netherlands
Antonius Ziekenhuis
Sneek, Provincie Friesland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Dyspnea
Change in Dyspnea on VAS analogue scale (AUC) VAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect). The change in Dyspnea VAS means higher score is better outcomes. Individual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated
Time frame: From baseline to Day 4
Diuretic Response
Weight change from baseline per 40 mg of Furosemide equivalent
Time frame: Total weight change from baseline to Day 4
Length of Stay
Hospital stay of Index admission
Time frame: within 60 days
Plasma NTproBNP
Change in NTproBNP
Time frame: From baseline to Day 4
Death and/or Heart Failure Re-admission
Death and/or heart failure re-admission at day 30
Time frame: Day 30
Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60
Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60
Time frame: 60 days
All Cause Mortality
All Cause Mortality at 60 days
Time frame: 60 day
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