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Should heart failure patients stay on jardiance in the hospital? new trial aims to find out

NCT ID NCT07038356

Disease control Sponsor: Christian Schulze Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This phase 3 trial studies whether patients with acute decompensated heart failure who are already taking an SGLT2 inhibitor like empagliflozin should continue it during hospitalization. About 536 participants will either keep taking empagliflozin or switch to a placebo while in the hospital, then all take empagliflozin after discharge. The goal is to see if continuing the drug reduces death, heart failure events, and kidney decline over 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empagliflozin (Jardiance)
What this could lead to
If successful, this could show that continuing empagliflozin during a heart failure hospital stay is safe and helps prevent death or further heart problems.
What could go wrong
This is a mid-stage trial with 536 participants, so results may not apply to everyone. There is a risk that continuing the drug offers no benefit or causes side effects like kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 536 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) * Need for hemofiltration or any other form of extracorporeal therapy * 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

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute decompensated heart failure (ADHF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin

    NOT_YET_RECRUITING

    Berlin, 12203, Germany

  • Herzzentrum Dresden GmbH Universitaetsklinik

    RECRUITING

    Dresden, 01307, Germany

  • Herzzentrum Leipzig GmbH

    RECRUITING

    Leipzig, 04289, Germany

  • Jena University Hospital

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Kerckhoff-Klinik GmbH

    RECRUITING

    Bad Nauheim, 61231, Germany

  • LMU Klinikum Muenchen AöR

    RECRUITING

    München, 81377, Germany

  • Rostock University Medical Center

    RECRUITING

    Rostock, 18057, Germany

  • Universitaetsklinikum Leipzig AöR

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsmedizin Goettingen

    RECRUITING

    Göttingen, 37075, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    RECRUITING

    Mainz, 55131, Germany

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III

    NOT_YET_RECRUITING

    Halle, 06120, Germany

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