Empagliflozin Functional Capacity - Non-Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,431
- 试验地点
- 349
- 主要终点
- Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Empagliflozin-treated patients
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).
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
时间窗: 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.
次要结局
- Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin(At baseline and at Week 24.)
- Number of Participants With Comorbidities(At baseline.)
- Number of Participants With Concomitant Heart-failure (HF) Related Medication(At baseline.)
- Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline(Up to 6 months prior to baseline visit.)