A Phase 3 clinical trial investigating the effects of continued administration of empagliflozin in patients with Acute Decompensated Heart Failure (ADHF) reached its primary completion on April 30, 2026. The study, identified as NCT07038356, enrolled 536 participants to assess the drug's role in this critical patient population.
Background
The trial, titled "Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure," aimed to test the hypothesis that continuing empagliflozin during decongestive therapy for hospitalized patients with ADHF is not inferior compared to discontinuing the therapy during the acute hospitalization.
Trial design
The Phase 3 study (NCT07038356) was designed to enroll 536 participants diagnosed with Acute Decompensated Heart Failure (ADHF). Participants were randomized to receive either one empagliflozin 10 mg oral tablet daily or a matching placebo. This treatment was administered during the in-hospital stay, for a maximum of 30 days, and was followed by treatment with empagliflozin 10 mg daily after discharge for all participants.
What this means
The primary completion of this Phase 3 trial signifies that all participants have completed the final data collection for the primary outcome. Researchers will now proceed with data analysis to determine whether the continued administration of empagliflozin demonstrates non-inferiority compared to therapy cessation in patients hospitalized with ADHF. The results are anticipated to provide crucial insights into managing heart failure in acute settings.
Source
Information regarding the primary completion of trial NCT07038356 was obtained from ClinicalTrials.gov, a public database of clinical studies. The event date for this update was April 30, 2026, as reported on clinicaltrials.gov.