Effects of continued administration of empagliflozin in patients with heart failure on active SGLT2 inhibitor treatment admitted for acute decompensated heart failure

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Friedrich-Schiller-Universitaet Jena

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

25 Nov 2025 → ongoing

Decision date (initial)

2025-08-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boehringer Ingelheim International GmbH, Binger Straße 173, 55216 Ingelheim am Rhein, Germany

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To assess the non-inferiority of continued administration of empagliflozin 10 mg versus placebo plus standard medical care in patients admitted with acute decompensated heart failure (ADHF) with prior treatment using a SGLT2 inhibitor on the combined endpoint of all-cause mortality, HF hospitalization and worsening renal function at 90 days after admission.

Secondary objectives 1

1. To evaluate the effects of continued administration of empagliflozin versus placebo plus standard medical care in patients with ADHF on urine output, diuretic efficiency, quality-of-life and the need for further administration of diuretics.

Conditions and MedDRA coding

acute decompensated heart failure

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor
2. Brain Natriuretic Peptide (BNP) >100 pg/ml or N-terminal pro-BNP (NT-proBNP) >300 pg/ml
3. Written informed consent obtained
4. Negative pregnancy test for women of childbearing potential

Exclusion criteria 13

1. Type 1 diabetes mellitus
2. Chronic Kidney Disease (CKD) with eGFR<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment
3. Acute kidney injury (AKI) requiring dialysis treatment
4. Known intolerance to empagliflozin
5. Acute heart failure without signs of congestion (“dry” patient)
6. Indication for coronary angiography or any foreseeable administration of a contrast media
7. Need for hemofiltration or any other form of extracorporeal therapy
8. Planned surgery
9. Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)
10. 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)
11. Incapacity to understand and / or to provide written informed consent
12. Obvious uncontrolled substance abuse
13. Pregnancy, breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The study uses a four-step hierarchical composite primary endpoint: 1) time to all-cause death (day 90) 2) number of heart failure events per patient (day 90) 3) time to first heart failure event (day 90) 4) eGFR decrease from baseline to day 90 (with a between-patient threshold defined as ≥5 ml/min/1.73 m²)

Secondary endpoints 14

1. Cardiovascular and total mortality on day 90
2. Number of patients alive and without re-hospitalization on day 90
3. Re-hospitalization after initial discharge, including reason (time to first re-hospitalization after discharge, numbers of re-hospitalizations)
4. Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90
5. Daily and cumulative urine output (UOP) measured from day 1 to day 6
6. Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6
7. Change in body weight from baseline to day 1, day 3, day 6, discharge, day 30, and day 90
8. Renal function at baseline, day 3, day 6, day 30, and day 90 : •Decrease in eGFR of >20 ml/min/1.73 m2 •Doubling of serum creatinine •Need for renal replacement therapy •Total urinary sodium excretion and fractional excretion of sodium
9. Liver function (bilirubin, serum aminotransferases, relevant change in coagulation status) at baseline, day 3, day 6, day 30, and day 90
10. Change in NT-proBNP (alternatively calculated from BNP) from baseline to day 6, day 30, and day 90
11. Quality of life (EQ-5D-3L questionnaire) on day 0, at hospital discharge, and on day 30
12. Severity of HF (KCCQ-12 questionnaire) on day 0, at hospital discharge, and on day 30
13. IMC / ICU and hospital length of stay
14. Single parameters of primary endpoint

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Friedrich-Schiller-Universitaet Jena

Sponsor organisation

Friedrich-Schiller-Universitaet Jena

Address

Am Klinikum 1, Lobeda Lobeda

City

Jena

Postcode

07747

Country

Germany

Scientific contact point

Organisation

Friedrich-Schiller-Universitaet Jena

Contact name

Prof. Dr. Christian Schulze

Public contact point

Organisation

Friedrich-Schiller-Universitaet Jena

Contact name

Prof. Dr. Christian Schulze

Third parties 1

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications