Trial results for the Emp-Activity: Empagliflozin Functional Capacity study (NCT05350202) were posted on ClinicalTrials.gov on 2025-08-26. The study, investigating empagliflozin in patients with heart failure, reported a mean change of up to 17.61 units in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores for empagliflozin-treated patients.
Background
Empagliflozin is a medication used in the treatment of various conditions, including heart failure. This study focused on its use in patients with chronic Heart Failure in a routine clinical setting.
Trial design
The Emp-Activity: Empagliflozin Functional Capacity study (NCT05350202) was a multinational non-interventional study that enrolled 3431 participants with chronic Heart Failure. The study was designed with a two-cohort approach to assess demographics, disease, and treatment patterns. One cohort received a first prescription of empagliflozin as routine therapy for heart failure, while the other cohort received heart failure therapy with drugs of a different mechanism of action. Treatment decisions were made by physicians independently of study participation.
Key results
The study reported changes in functional capacity and symptom burden for patients newly treated with empagliflozin. For the outcome, "Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice" in Empagliflozin-treated Patients, the following mean changes were observed:
- A mean change of 14.66 Units on a scale (Standard Deviation: 18.44).
- A mean change of 17.61 Units on a scale (Standard Deviation: 21.04).
- A mean change of 16.47 Units on a scale (Standard Deviation: 18.86).
Regarding the "Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin" in Empagliflozin-treated Patients, the following participant counts were reported:
- 337 Participants
- 1388 Participants
- 54 Participants
- 0 Participants
- 5 Participants
- 184 Participants
- 13 Participants
- 37 Participants
- 730 Participants
What this means
The observed mean changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, ranging up to 17.61 units, suggest an improvement in symptoms and functional status for patients with chronic heart failure newly treated with empagliflozin in a routine clinical setting. These findings contribute to the understanding of empagliflozin's impact on patient-reported outcomes in heart failure management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05350202, titled "Emp-Activity: Empagliflozin Functional Capacity," were posted on 2025-08-26 on clinicaltrials.gov.