Emp-Activity: Empagliflozin Functional Capacity

Study Overview
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Brief Summary
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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.

Official Title
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Empagliflozin Functional Capacity - Non-Interventional Study

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Empagliflozin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort receiving empagliflozin<br>Patients will receive first prescription of empagliflozin as routine therapy for Heart Failure with reduced Ejection Fraction (HFrEF). | Drug: Empagliflozin<br>* Empagliflozin<br>* Other names: Jardiance®;|
| Cohort receiving drugs with another mechanism of action<br>Patients will receive Heart Failure therapy with drugs with another mechanism of action. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical summary score (CSS) in patients treated with empagliflozin | KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. The score is transformed to a range of 0 - 100, in which higher scores reflect better health status. | At baseline, at week 24. | 
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score (TSS) in patients treated with empagliflozin | KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-TSS incorporates the symptom frequency (4 items) and symptom burden (3 items) domains into a single summary score. The score is transformed to a range of 0-100, in which a higher score reflects better health status. | At baseline, at week 24. | 
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (OSS) 1 in patients treated with empagliflozin | KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-OSS incorporates all domains into a score, ranging from 0-100, in which a higher score reflects better health status. | At baseline, at week 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin | Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin. | At baseline, at week 24. | 
| Patient characteristics | To evaluate patient characteristics in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). | At baseline. | 
| Frequency of comorbidities | To evaluate the frequency of comorbidities in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). | At baseline. | 
| Treatment patterns | To evaluate treatment patterns in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). | At baseline. |