ClinicalTrials.gov posted results on 2026-08-10 for NCT05236673, a completed post-marketing surveillance study of empagliflozin in Korean patients with chronic heart failure. The record enrolled 676 participants and focused on safety in routine clinical practice.

Background

The study evaluated Jardiance® in patients with chronic heart failure, including New York Heart Association class II-IV as described in the trial summary. The posted record identifies the work as post-marketing surveillance rather than a randomized efficacy trial.

Trial design

This was a completed surveillance study in a chronic heart failure population. The posted record lists 676 enrolled participants and does not provide a phase assignment or comparator arm in the results summary.

Key results

Among 676 treated patients, 116 had adverse events, 39 had unexpected adverse events, and 1 had an unexpected adverse drug reaction. Serious adverse events were reported in 33 patients, while 0 patients had a serious adverse drug reaction.

Drug-related adverse events were reported in 27 patients, and non-serious adverse drug reactions were also reported in 27 patients. Adverse events leading to discontinuation were reported in 16 patients. The record also lists 1 adverse event of special interest.

For heart-failure outcomes after 12 weeks and 24 weeks of treatment from baseline, the record reported 31 and 33 participants with hospitalization for heart failure, respectively, and 2 participants with cardiovascular death. Paired t-tests showed changes in ejection fraction at week 12 and week 24 versus baseline with p values of 0.0001 and 0.0004, and changes in NT-proBNP with p values of 0.0003 and 0.0065. HbA1c changes were not statistically significant, with p values of 0.1987 and 0.0659.

What this means

The posted results add real-world safety information for empagliflozin in Korean patients with chronic heart failure. The surveillance record shows adverse events and discontinuations occurred, but it also reported 0 serious adverse drug reactions and statistically significant changes in ejection fraction and NT-proBNP over time.

Source

This information is based on ClinicalTrials.gov results for NCT05236673 posted on 2026-08-10. The record is available at clinicaltrials.gov.