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Empagliflozin 10 MG Oral Tablet [Jardiance] / Acute Decompensated Heart Failure (ADHF) · Phase 3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 non-inferiority RCT examining whether continuing empagliflozin during hospitalization for acute decompensated heart failure is non-inferior to treatment cessation. The study is actively recruiting and has not yet reported results; no efficacy or safety data are available in this registry record.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Acute Decompensated Heart Failure (ADHF); age from 18 Years. Intervention: intervention. Compared with: control — Placebo Comparator. n = 536. 12 sites: Germany.
This is a registered Phase 3 non-inferiority RCT examining whether continuing empagliflozin during hospitalization for acute decompensated heart failure is non-inferior to treatment cessation. The study is actively recruiting and has not yet reported results; no efficacy or safety data are available in this registry record.
Study is recruiting and no results are posted; no efficacy or safety data are available
Once results are reported, this trial may clarify whether SGLT2 inhibitors should be continued during acute heart failure hospitalization, potentially changing inpatient management practice. Current readers should note no evidence exists yet from this study.
This is a Phase 3 RCT still recruiting with no results posted; the registry record describes a planned non-inferiority design testing empagliflozin continuation in acute decompensated heart failure, but no efficacy or safety data are available.
As stated by the source record.
Quoted from the source exactly as published.
Once results are reported, this trial may clarify whether SGLT2 inhibitors should be continued during acute heart failure hospitalization, potentially changing inpatient management practice. Current readers should note no evidence exists yet from this study.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07038356). This is a study registration, not published results. Lead sponsor: Christian Schulze. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 536 participants (ESTIMATED). Conditions: Acute Decompensated Heart Failure (ADHF). Interventions: DRUG: Empagliflozin 10 MG Oral Tablet [Jardiance]; DRUG: Placebo. Primary outcome measures: 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 , day 90. Brief summary: 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
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.