Early Treatment of Heart Failure: a Non-interventional Observational Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF - UK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Time to dapagliflozin treatment discontinuation
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; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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 date of initiation of treatment with dapagliflozin
- •Patient received/receiving treatment with dapagliflozin for HFrEF (EF ≤40%) 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 SGLT2i treatment
- •Initiation of dapagliflozin outside of local HF label
- •Diagnosis of Type 1 diabetes prior to enrolment
结局指标
主要结局
Time to dapagliflozin treatment discontinuation
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 dapagliflozin treatment changes
时间窗: Baseline to 12 months
The number of participants who switch to another HF medication other than dapagliflozin.
Number of glucose lowering medication initiation
时间窗: Baseline to 12 months
The number of participants who initiate new glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication dosage changes
时间窗: Baseline to 12 months
The percentage of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Number of dapagliflozin treatment discontinuation
时间窗: Baseline to 12 months
The number of participants who discontinued treatment with dapagliflozin.
Percentage of dapagliflozin treatment discontinuation
时间窗: Baseline to 12 months
The percentage of participants who discontinued treatment with dapagliflozin.
Percentage of dapagliflozin treatment changes
时间窗: Baseline to 12 months
The percentage of participants who switch to another HF medication other than dapagliflozin.
Time to other heart failure treatment discontinuation
时间窗: Baseline to 12 months
Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
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.
Number of reasons for dapagliflozin treatment discontinuation
时间窗: Baseline to 12 months
Number of reason for dapagliflozin treatment discontinuation as noted by a health care professional will extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.
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.
Percentage of other heart failure treatment initiation
时间窗: Baseline to 12 months
The percentage of participants who initiate new heart failure medication other than dapagliflozin.
Number of other heart failure treatment discontinuation
时间窗: Baseline to 12 months
The number of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Number of glucose lowering medication discontinuation
时间窗: Baseline to 12 months
The number of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication discontinuation
时间窗: Baseline to 12 months
The percentage of participants who discontinue treatment with glucose lowering medication other than dapagliflozin.
Proportion of reasons for dapagliflozin treatment discontinuation
时间窗: Baseline to 12 months
Proportion of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.
Percentage of other heart failure treatment dosage changes
时间窗: Baseline to 12 months
The percentage of participants with dosage changes for heart failure medication other than dapagliflozin.
Percentage of other heart failure treatment discontinuation
时间窗: Baseline to 12 months
The percentage of participants who discontinue treatment with heart failure medication other than dapagliflozin.
Time to glucose lowering medication discontinuation
时间窗: Baseline to 12 months
Time from initiation of glucose lowering medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.
Number of glucose lowering medication dosage changes
时间窗: Baseline to 12 months
The number of participants with dosage changes for glucose lowering medication other than dapagliflozin.
Percentage of glucose lowering medication initiation
时间窗: Baseline to 12 months
The percentage of participants who initiate new glucose lowering medication other than dapagliflozin.
次要结局
- Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score(Measured at 3, 6, 9 and 12 months)
- Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score(Measured at 3, 6, 9 and 12 months)
- Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire(Measured at 3, 6, 9 and 12 months)