Early Treatment of Heart Failure: a Non-interventional Study Program of Patients With Heart Failure and Initiated on Dapagliflozin (EVOLUTION-HF DEallEF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 831
- 试验地点
- 48
- 主要终点
- Dose changes of dapagliflozin
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). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany.
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 130 Years（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 date of initiation of treatment with dapagliflozin
- •Patient received/receiving treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with:
- •preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%)
- •OR reduced ejection fraction (HFrEF EF ≤40%)
- •Patient is enrolled within 14 to 90 days following initiation of dapagliflozin
- •Signed and dated informed consent prior to enrolment in the study
排除标准
- •Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
- •Prior treatment with dapagliflozin or other SGLT2i treatment
- •Initiation of dapagliflozin outside of the local HF label
- •Diagnosis of Type 1 diabetes prior to enrolment
- •Current or planned participation in a clinical trial using an investigational medical product for treating HF
- •Patient is involved in the planning and/or conduction of the study
- •Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC
研究组 & 干预措施
HFmrEF
Adult patients with mildly reduced ejection fraction (HFmrEF; EF 41-49%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure.
HFrEF
Adult patients with reduced ejection fraction (HFrEF; EF ≤40%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure.
HFpEF
Adult patients with preserved ejection fraction (HFpEF; EF≥50%) who receive treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure.
结局指标
主要结局
Dose changes of dapagliflozin
时间窗: Baseline to 12 months
The number of participants with doses changes for 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.
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.
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 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.
Reasons for discontinuation of dapagliflozin
时间窗: Baseline to 12 months
Reasons for discontinuation (from the perspective of the prescriber) of patients initiated on dapagliflozin for HF will be described.
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 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.
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 (from the perspective of the prescriber).
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.
Number of patients with dapagliflozin treatment interruptions
时间窗: Baseline to 12 month
The number of participants who discontinue treatment with dapagliflozin.
Treatment switches from dapagliflozin to other SGLT2i
时间窗: Baseline to 12 months
The number of participants who switch from dapagliflozin to another SGLT2i (Sodium-glucose cotransporter-2 inhibitor) treatment for HF.
次要结局
- Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire(Measured at 3, 6, 9 and 12 months)
- 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)