Emp-Activity: Empagliflozin Functional Capacity
- Registration Number
- NCT05350202
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3431
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Empagliflozin-treated patients Empagliflozin Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
- Primary Outcome Measures
Name Time Method Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice At baseline and at week 24. Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \[Week 24\] - \[Baseline\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.
- Secondary Outcome Measures
Name Time Method Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin At baseline and at Week 24. This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort.
Number of Participants With Comorbidities At baseline. Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.
Number of Participants With Concomitant Heart-failure (HF) Related Medication At baseline. Number of patients who took concomitant HF-related medication.
Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline Up to 6 months prior to baseline visit. Number of patients hospitalized at least one time due to heart failure (HF).
Trial Locations
- Locations (349)
Dr. Mircheva
🇧🇬Burgas, Bulgaria
Dr. Yordanov
🇧🇬Haskovo, Bulgaria
MBAL Atanas Dafovski, Kardzhali
🇧🇬Kardzhali, Bulgaria
Dr. Krasteva
🇧🇬Kyustendil, Bulgaria
Dr. Todorov
🇧🇬Lovech, Bulgaria
Dr. Tsoneva
🇧🇬Lovech, Bulgaria
Dr. Pavlov
🇧🇬Parvomay, Bulgaria
Medical Center, Pazardjik
🇧🇬Pazardzhik, Bulgaria
Dr. Stankova
🇧🇬Pernik, Bulgaria
assoc.prof. Gospodinov
🇧🇬Pleven, Bulgaria
Scroll for more (339 remaining)Dr. Mircheva🇧🇬Burgas, Bulgaria