N/A
N=3,431
Emp-Activity: Empagliflozin Functional Capacity
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05350202 ↗Enrolled (actual)
3,431
Serious AEs
2.2%
Results posted
Aug 2025
Primary outcome: Primary: Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice — 14.66; 17.61; 16.47 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Empagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice |
14.66; 17.61; 16.47 | — |
| SECONDARY Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin |
337; 1388; 54; 0; 5; 184 | — |
| SECONDARY Number of Participants With Comorbidities |
130; 6; 103; 3; 626; 18 | — |
| SECONDARY Number of Participants With Concomitant Heart-failure (HF) Related Medication |
63; 4; 868; 19; 68; 4 | — |
| SECONDARY Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline |
284; 6 | — |
Summary
This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to study participation
- Male and female patients ≥ 18 years at Visit 1
- Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel
- Patients with diagnosis of chronic heart failure NYHA Class 2-4
- Treatment-naïve for SGLT2i at visit 1
- Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s)
Exclusion Criteria
- Missing physician's diagnosis of chronic heart failure
- Patients hospitalized at visit 1
- Life expectancy ≤ 12 months according to physician's assessment
- Lack of informed consent
- Pregnant or lactating females
- Participation in a parallel interventional clinical trial
- Chosen treatment with another SGLT2i drug than empagliflozin
- Having been enrolled into the non-empagliflozin-arm of this non-interventional study
- Current or prior treatment with SGLT2i at visit 1
- Patients with contraindications according to current Summary of Product Characteristics (SmPC)
- Patients with dependency or relationship to the treating physician
Data sourced from ClinicalTrials.gov (NCT05350202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.