Emp-Activity: Empagliflozin Functional Capacity
Study Details
Study Description
Brief Summary
This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with Heart Failure with reduced Ejection Fraction (HFrEF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HFrEF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HFrEF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort receiving empagliflozin Patients will receive first prescription of empagliflozin as routine therapy for Heart Failure with reduced Ejection Fraction (HFrEF). |
Drug: Empagliflozin
Empagliflozin
Other Names:
|
| Cohort receiving drugs with another mechanism of action Patients will receive Heart Failure therapy with drugs with another mechanism of action. |
Outcome Measures
Primary Outcome Measures
- Change of Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical summary score (CSS) in patients treated with empagliflozin [At baseline, at week 24.]
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.
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score (TSS) in patients treated with empagliflozin [At baseline, at week 24.]
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.
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (OSS) 1 in patients treated with empagliflozin [At baseline, at week 24.]
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.
Secondary Outcome Measures
- Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin [At baseline, at week 24.]
Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin.
- Patient characteristics [At baseline.]
To evaluate patient characteristics in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF).
- Frequency of comorbidities [At baseline.]
To evaluate the frequency of comorbidities in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF).
- Treatment patterns [At baseline.]
To evaluate treatment patterns in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent prior to study participation
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Male and female patients ≥ 18 years at Visit 1
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Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel
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Patients with diagnosis of chronic heart failure New York Heart Association (NYHA) Class 2-4 with reduced left ventricular ejection fraction of ≤ 40%
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Treatment-naïve for Sodium-Glucose Co-Transporter 2 (SGLT2i) at visit 1
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Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen Heart Failure with reduced Ejection Fraction (HFrEF) drug(s)
Exclusion Criteria:
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Missing physician's diagnosis of chronic HFrEF
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Patients hospitalized at visit 1
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Life expectancy ≤ 12 months according to physician's assessment
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Lack of informed consent
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Pregnant or lactating females
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Participation in a parallel interventional clinical trial
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Chosen treatment with another SGLT2i drug than empagliflozin
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Having been enrolled into the non-empagliflozin-arm of this non-interventional study
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Current or prior treatment with SGLT2i at visit 1
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Patients with contraindications according to current Summary of Product Characteristics (SmPC)
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Patients with dependency or relationship to the treating physician
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1245-0259