Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Empagliflozin 10 MG Oral Tablet [Jardiance] for Acute Decompensated Heart Failure (ADHF)

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. randomly assigned treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching dummy treatment (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.

Official registry: https://clinicaltrials.gov/study/NCT07038356 · Christian Schulze · enrollment listed as 536

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empagliflozin 10 MG Oral Tablet [Jardiance], or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 536 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure

Interventions: Empagliflozin 10 MG Oral Tablet [Jardiance], Placebo

Primary outcome (registry wording): Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

12 listed

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NCT04278404 · Official ClinicalTrials.gov record · Duke University

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FAQ about this NCT record

Is NCT07038356 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07038356?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07038356?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary