Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure (EMPA-CON)

Christian Schulze

Status and phase: Enrolling; Phase 3

Conditions: Acute Decompensated Heart Failure (ADHF)

Treatments: Drug: Placebo; Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Study type: Interventional

Funder types: Other

Identifiers

NCT07038356

EMPA-CON_ZKSJ0162

2024-517977-26-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization.

Randomized treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching placebo during the in-hospital stay (up to a maximum of 30 days), followed by treatment with empagliflozin 10 mg daily after discharge (but no later than day 31) until day 90.

The primary outcome measure is the combined hierarchical endpoint of all-cause mortality, heart failure hospitalization and worsening renal function at 90 days after admission.

Secondary outcome measures are the effects on urine output, diuretic efficiency, quality-of-life and the need for further administration of diuretics.

Participants will

• Take one tablet of study medication once daily (day 1 to day 90)
• Restrict fluid intake to 1.5 liters of fluid per day and record the daily fluid intake for the study from day 1 to day 6 in the patient diary
• Measure the urine output (day 1 to day 6)
• Fill in Questionnaires (EQ-5D-3L (3-level version of the EuroQol five dimensional descriptive system), KCCQ-12 (Kansas City Cardiomyopathy Questionnaire comprising 12 items)) on day 0 (Baseline), at hospital discharge, and on day 30

Enrollment: 536 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor
• Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NTproBNP) >300 pg/ml
• Written informed consent obtained
• Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception

Exclusion criteria

• Type 1 diabetes mellitus
• Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment
• Acute kidney injury (AKI) requiring dialysis treatment
• Known intolerance to empagliflozin
• Acute heart failure without signs of congestion ("dry" patient)
• Indication for coronary angiography or any foreseeable administration of a contrast media
• Need for hemofiltration or any other form of extracorporeal therapy
• Planned surgery
• Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)
• Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
• Incapacity to understand and / or to provide written informed consent
• Obvious uncontrolled substance abuse
• Pregnancy, breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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536 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

Randomized treatment with placebo (one tablet) daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90.

Treatment:

Drug: Placebo

intervention

Active Comparator group

Description:

Drug: Empagliflozin (10 mg/day), film-coated tablet Randomized treatment with 10 mg empagliflozin (Jardiance, one tablet) or placebo daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90

Treatment:

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]