Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - GREECE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Number of dapagliflozin treatment changes
研究概览
简要总结
Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality. Dapagliflozin has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in May 2020 and November 2020 respectively, for HF with reduced ejection fraction (HFrEF). The overall aim of this study is to describe the characteristics of patients initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns as well as patient-reported outcomes (PROs) including quality of life.
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
- •Age ≥18 years as of study index date; the study index date is the date of initiation of treatment with dapagliflozin
- •Patient received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction in accordance with the local dapagliflozin product label
- •Signed and dated informed consent prior to enrolment in the study
排除标准
- •Patient is enrolled less than 14 days or more than 60 days following initiation of dapagliflozin
- •Prior treatment with dapagliflozin or other Sodium Glucose co-transporter 2 inhibitor treatment
- •Initiation of dapagliflozin outside of local Heart Failure label
- •Diagnosis of Type 1 diabetes prior to enrolment
结局指标
主要结局
Number of dapagliflozin treatment changes
时间窗: Baseline to 12 months
The number of participants who switch from dapagliflozin to another Heart Failure medication.
Time to discontinuation of dapagliflozin
时间窗: Baseline to 12 months
Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.
Number of reasons for dapagliflozin treatment discontinuation
时间窗: Baseline to 12 months
Number of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will be extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.
Baseline characteristics (demographic and clinical)
时间窗: Baseline to 12 months
To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction
Number of other heart failure treatment initiation
时间窗: Baseline to 12 months
The number of participants who initiate new heart failure medication other than dapagliflozin.
Number of other heart failure treatment dosage changes
时间窗: Baseline to 12 months
The number of participants with dosage changes for heart failure medication other than dapagliflozin.
Time to other HF medication discontinuation
时间窗: Baseline 12 months
Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
次要结局
- Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score(Measured at enrollment and 3, 6, 9 and 12 months)
- Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire(Measured at enrollment, 3, 6, 9 and 12 months)